{
 "dataset": "smartbeautydevices.com: FDA 510(k) and De Novo records for at-home beauty and skin device product codes",
 "fetched": "2026-10-12",
 "openfda_last_updated": "2026-09-28",
 "method": {
  "source": "openFDA device classification and device 510(k) endpoints (https://open.fda.gov/apis/device/), plus FDA-hosted decision documents on accessdata.fda.gov",
  "queries": [
   {
    "code": "OHS",
    "classification": "https://api.fda.gov/device/classification.json?search=product_code:OHS",
    "k510": "https://api.fda.gov/device/510k.json?search=product_code:OHS&limit=1000",
    "total": 163
   },
   {
    "code": "OLP",
    "classification": "https://api.fda.gov/device/classification.json?search=product_code:OLP",
    "k510": "https://api.fda.gov/device/510k.json?search=product_code:OLP&limit=1000",
    "total": 51
   },
   {
    "code": "OZC",
    "classification": "https://api.fda.gov/device/classification.json?search=product_code:OZC",
    "k510": "https://api.fda.gov/device/510k.json?search=product_code:OZC&limit=1000",
    "total": 1
   },
   {
    "code": "OHT",
    "classification": "https://api.fda.gov/device/classification.json?search=product_code:OHT",
    "k510": "https://api.fda.gov/device/510k.json?search=product_code:OHT&limit=1000",
    "total": 165
   },
   {
    "code": "OAP",
    "classification": "https://api.fda.gov/device/classification.json?search=product_code:OAP",
    "k510": "https://api.fda.gov/device/510k.json?search=product_code:OAP&limit=1000",
    "total": 114
   },
   {
    "code": "PAY",
    "classification": "https://api.fda.gov/device/classification.json?search=product_code:PAY",
    "k510": "https://api.fda.gov/device/510k.json?search=product_code:PAY&limit=1000",
    "total": 12
   },
   {
    "code": "NFO",
    "classification": "https://api.fda.gov/device/classification.json?search=product_code:NFO",
    "k510": "https://api.fda.gov/device/510k.json?search=product_code:NFO&limit=1000",
    "total": 82
   },
   {
    "code": "QAI",
    "classification": "https://api.fda.gov/device/classification.json?search=product_code:QAI",
    "k510": "https://api.fda.gov/device/510k.json?search=product_code:QAI&limit=1000",
    "total": 26
   }
  ],
  "indications": "Cut verbatim from the FDA-hosted decision PDF (Indications for Use form, eSTAR form, 510(k) summary section, or De Novo decision summary) with pdftotext; whitespace collapsed, line-end hyphens joined, ligature and private-use glyphs normalized, nothing else changed. Published (indications) only when the extraction is clean and the page is not a scan. Withheld (indications_withheld, with indications_status giving the reason) when the page is a scanned image whose text is machine-read, when the page could not be confirmed, or when the text contains words that look like reading errors. Null in both when the PDF has no text layer, is missing, or no clean statement could be located.",
  "user_agent": "Mozilla/5.0 (Macintosh; Intel Mac OS X 10_15_7) AppleWebKit/537.36 (KHTML, like Gecko) Chrome/124 Safari/537.36",
  "openfda_disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
 },
 "codes": [
  {
   "code": "OHS",
   "device_name": "Light Based Over The Counter Wrinkle Reduction",
   "definition": "Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.",
   "regulation_number": "878.4810",
   "device_class": "2",
   "medical_specialty": "General, Plastic Surgery",
   "third_party_flag": "N",
   "classification_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=OHS",
   "regulation_url": "https://www.ecfr.gov/current/title-21/section-878.4810",
   "records": 163
  },
  {
   "code": "OLP",
   "device_name": "Over-The-Counter Powered Light Based Laser For Acne",
   "definition": "The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.",
   "regulation_number": "878.4810",
   "device_class": "2",
   "medical_specialty": "General, Plastic Surgery",
   "third_party_flag": "N",
   "classification_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=OLP",
   "regulation_url": "https://www.ecfr.gov/current/title-21/section-878.4810",
   "records": 51
  },
  {
   "code": "OZC",
   "device_name": "Over The Counter Thermal Treatment For Acne.",
   "definition": "For the treatment of mild to moderate inflammatory acne.",
   "regulation_number": "890.5740",
   "device_class": "2",
   "medical_specialty": "Physical Medicine",
   "third_party_flag": "N",
   "classification_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=OZC",
   "regulation_url": "https://www.ecfr.gov/current/title-21/section-890.5740",
   "records": 1
  },
  {
   "code": "OHT",
   "device_name": "Light Based Over-The-Counter Hair Removal",
   "definition": "Over-the-counter device uses thermal energy to kill hair follicles for hair removal.",
   "regulation_number": "878.4810",
   "device_class": "2",
   "medical_specialty": "General, Plastic Surgery",
   "third_party_flag": "N",
   "classification_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=OHT",
   "regulation_url": "https://www.ecfr.gov/current/title-21/section-878.4810",
   "records": 165
  },
  {
   "code": "OAP",
   "device_name": "Laser, Comb, Hair",
   "definition": "Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v",
   "regulation_number": "890.5500",
   "device_class": "2",
   "medical_specialty": "Physical Medicine",
   "third_party_flag": "N",
   "classification_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=OAP",
   "regulation_url": "https://www.ecfr.gov/current/title-21/section-890.5500",
   "records": 114
  },
  {
   "code": "PAY",
   "device_name": "Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction",
   "definition": "An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.",
   "regulation_number": "878.4420",
   "device_class": "2",
   "medical_specialty": "General, Plastic Surgery",
   "third_party_flag": "N",
   "classification_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=PAY",
   "regulation_url": "https://www.ecfr.gov/current/title-21/section-878.4420",
   "records": 12
  },
  {
   "code": "NFO",
   "device_name": "Stimulator, Transcutaneous Electrical, Aesthetic Purposes",
   "definition": "",
   "regulation_number": "882.5890",
   "device_class": "2",
   "medical_specialty": "Neurology",
   "third_party_flag": "Y",
   "classification_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=NFO",
   "regulation_url": "https://www.ecfr.gov/current/title-21/section-882.5890",
   "records": 82
  },
  {
   "code": "QAI",
   "device_name": "Powered Microneedle Device",
   "definition": "A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.",
   "regulation_number": "878.4430",
   "device_class": "2",
   "medical_specialty": "General, Plastic Surgery",
   "third_party_flag": "N",
   "classification_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=QAI",
   "regulation_url": "https://www.ecfr.gov/current/title-21/section-878.4430",
   "records": 26
  }
 ],
 "records": [
  {
   "id": "K261977",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-09-25",
   "date_received": "2026-06-12",
   "applicant": "Cyden Limited",
   "device_name": "Braun Aura 9 (6042)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261977",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261977.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 5,
   "indications_withheld": "The Braun Aura 9 is intended for the removal of unwanted hair. The Braun Aura 9 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K262183",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-09-24",
   "date_received": "2026-06-29",
   "applicant": "Shenzhen Nuon Medical Equipment Co., Ltd.",
   "device_name": "Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262183",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K262183.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K262254",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-09-23",
   "date_received": "2026-07-02",
   "applicant": "Guangdong Ashmore Health Technology Co., Ltd.",
   "device_name": "Hair Growth Comb (X-GC01)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262254",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K262254.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K262524",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-09-18",
   "date_received": "2026-07-22",
   "applicant": "ONE BEAUTY Technology Co., Ltd.",
   "device_name": "Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262524",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K262524.pdf",
   "indications": "The Sapphire Cooling IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K261370",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-09-16",
   "date_received": "2026-04-27",
   "applicant": "Guangdong Newdermo Biotech Co., Ltd.",
   "device_name": "LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261370",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261370.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K262861",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-09-11",
   "date_received": "2026-08-13",
   "applicant": "Xtreem Pulse, LLC",
   "device_name": "PureLift Pro Max",
   "product_code": "NFO",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262861",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K262861.pdf",
   "indications": "Intended for facial stimulation and indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K260387",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-08-31",
   "date_received": "2026-02-06",
   "applicant": "Hironic Co., Ltd.",
   "device_name": "SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260387",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260387.pdf",
   "indications": null,
   "indications_status": "no document"
  },
  {
   "id": "K260767",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-08-31",
   "date_received": "2026-03-09",
   "applicant": "Kam Yuen Plastic Products , Ltd.",
   "device_name": "Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260767",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260767.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K261602",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-08-10",
   "date_received": "2026-05-14",
   "applicant": "Shenzhen Goodwind Technology Development Co., Ltd.",
   "device_name": "Eye Recovery Pro (PH-e03)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261602",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261602.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K261705",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-08-10",
   "date_received": "2026-05-22",
   "applicant": "Shenzhen Jianchao Intelligent Technology Co., Ltd.",
   "device_name": "Hair Removal Device (R3C16-G Pro, R3C16-V Pro)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261705",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261705.pdf",
   "indications": "Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K261601",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-08-07",
   "date_received": "2026-05-14",
   "applicant": "Shenzhen Chuangtong Yigou Technology Co., Ltd.",
   "device_name": "LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261601",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261601.pdf",
   "indications": "The LED Light Therapy Mask is an over-the-counter (OTC) device intended for the following uses: For Red+NIR Mode: Treatment of full-face wrinkles. For Blue+Red+NIR mode: Treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K261496",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-08-04",
   "date_received": "2026-05-06",
   "applicant": "Duplex International Trading Limited",
   "device_name": "LED Light Therapy Masks (PE748, PE749, PE756)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261496",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261496.pdf",
   "indications": "The LED Light Therapy Mask (Model: PE748) is an Over-the-Counter (OTC) device, the Red light mode (Red + Near-Infrared light) intended for treatment of wrinkles; The Purple Light (Red + Blue light) mode intended for mild to moderate inflammatory acne. The LED Light Therapy Mask (Model: PE749) is an Over-the-Counter (OTC) device, For the face mask: The Red light mode (Red + Near-Infrared light) intended for treatment of wrinkles; The Purple Light (Red + Blue light) mode intended for mild to moderate inflammatory acne. For the neck mask: The Red light mode (Red + Near-Infrared light) intended for treatment of wrinkles; The LED Light Therapy Mask (Model: PE756) is an Over-the-Counter (OTC) device, The Red light mode (Red + Near-Infrared light) intended for treatment of wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K261851",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-08-04",
   "date_received": "2026-06-03",
   "applicant": "Shenzhen Qianyu Technology Co., Ltd.",
   "device_name": "LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261851",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261851.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K261482",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-07-31",
   "date_received": "2026-05-05",
   "applicant": "Led Intellectual Properties, LLC",
   "device_name": "LightStim for Wrinkles (1984); LightStim for Acne (2038)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261482",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261482.pdf",
   "indications": "LightStim for Wrinkles is an Over-the-Counter device that is intended for the use in the treatment of full-face wrinkles. LightStim for Acne is an Over-the-Counter device that is intended for the use in the treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K260598",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-07-24",
   "date_received": "2026-02-24",
   "applicant": "iSMART Developments, Ltd.",
   "device_name": "5 Wavelength LED Facemask (TN2508)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260598",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260598.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K253932",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-07-23",
   "date_received": "2025-12-09",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "FACEGYM Pro Device (HD-109)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253932",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253932.pdf",
   "indications": "The FACEGYM Pro Device (Model: HD-109) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K261675",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-07-17",
   "date_received": "2026-05-21",
   "applicant": "Shenzhen Chuanghong Zhilian Technology Co., Ltd.",
   "device_name": "CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261675",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261675.pdf",
   "indications": "CHZL Red Light Therapy Hair Growth Cap (Model(s): CHZL-120BK-L52D,CHZL-120BKL53D,CHZL-120BK-L54D) is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV. The device is intended for use in adults (22 years of age and older).",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K261407",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-07-15",
   "date_received": "2026-04-29",
   "applicant": "Dongguan Miqiang Technology Co., Ltd.",
   "device_name": "XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261407",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261407.pdf",
   "indications": "XPREEN LED Light Therapy Masks are Over the Counter devices that are intended for the use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne. Red light: Treatment of full-face wrinkles. Yellow light: Repair and reduce wrinkles. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; and to temporarily increase local blood circulation. Blue light: Treatment of mild to moderate inflammatory acne. Red+Blue light: Treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K261473",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-07-01",
   "date_received": "2026-05-04",
   "applicant": "Termosalud S.L.",
   "device_name": "Chromix",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "ES",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261473",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261473.pdf",
   "indications": "The Chromix is an LED light therapy device which uses specific wavelengths of light, produced by light emitting diodes (LEDs). It is intended to emit energy in the red and infrared region of the light spectrum to provide treatment for full face wrinkles. The blue and red light spectrum is intended for the treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K261052",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-06-29",
   "date_received": "2026-03-31",
   "applicant": "Guangdong Newdermo Biotech Co., Ltd.",
   "device_name": "LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261052",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261052.pdf",
   "indications": "The LED Light Therapy Mask (Model: LED Face Mask Pro FAC08NA)is an Over-the-Counter (OTC) device. 1.Red light(630 nm): Intended for treatment of wrinkles. 2.Amber light (605 nm) : Intended for treatment of wrinkles. 3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of wrinkles. 4. Blue light(415 nm): Intended for treatment of mild to moderate inflammatory acne. 5. Blue and Red (415 nm and 630 nm): Intended for treatment of mild to moderate inflammatory acne. 6. Near-Infrared(830 nm): The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The LED Light Therapy Mask (Model: LED Chest Mask Pro FAC09NA)is an Over-the-Counter (OTC) device. 1.Red light(630 nm): Intended for treatment of wrinkles. 2.Amber light (605 nm) : Intended for treatment of wrinkles. 3.Red+Near-Infrared(630nm and 830 nm): Intended for treatment of wrinkles. 4. Near-Infrared(830 nm): The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K261253",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-06-26",
   "date_received": "2026-04-16",
   "applicant": "Ziree Co., Ltd.",
   "device_name": "Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261253",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261253.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K260946",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-06-18",
   "date_received": "2026-03-23",
   "applicant": "Guangdong Newdermo Biotech Co., Ltd.",
   "device_name": "LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260946",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260946.pdf",
   "indications": "The LED Light Therapy Mask adopts the latest LED light therapy technology, combining 6 kinds of Model: K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K. The LED Light Therapy Mask (Model:K9C-TK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Deep Red and Infrared light (660nm + 850nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. 3.Amber light(605nm): Intended for treatment of wrinkles. 4. Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne. 5.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne. The LED Light Therapy Mask (Models:K9C-K, K9P-YK, K9P-K) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Deep Red and Infrared light (660nm + 850nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. 3.Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne. 4.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne. The LED Light Therapy Mask(Model: FM-03BK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles. 1.Red light (630nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. The LED Light Therapy Mask (Model: FM-09K) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Red light (630nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. 3.Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne. 4.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253231",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-06-16",
   "date_received": "2025-09-29",
   "applicant": "Hubei Yjt Technology Co.,Ltd",
   "device_name": "Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253231",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253231.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 4,
   "indications_withheld": "Laser Hair Growth System is indicated to promote hair growth in males with androgenicalopecia who have NorwoodHamilton classifications of IIa-V or females with androgenicalopecia who have Ludwig-Savin Classifications of I-II and both with Skin Phototypes I-IV.",
   "indications_odd": [
    "androgenicalopecia"
   ]
  },
  {
   "id": "K254025",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-06-16",
   "date_received": "2025-12-16",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254025",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254025.pdf",
   "indications": "M1 is an over-the-counter device that is intended for emit energy in the red and infrared spectrum for use for the treatment of full face and decolletage wrinkles. M2,M3,M5 is an over-the-counter device that is intended for emit energy in the red,infrared, yellow spectrum for use for the treatment of full face wrinkles. M4 is intended for over-the-counter use to treat mild to moderate inflammatory acne on the face.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K260899",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-06-16",
   "date_received": "2026-03-18",
   "applicant": "Zdeer Technology (Henan) Co., Ltd.",
   "device_name": "Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260899",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260899.pdf",
   "indications": "The device is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K251684",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-06-05",
   "date_received": "2025-06-02",
   "applicant": "Alma Lasers, Inc.",
   "device_name": "Alma TED+ System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251684",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251684.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 4,
   "indications_withheld": "Alma TED+ System is indicated to treat Androgenetic Alopecia and promote hair growth infemales who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick SkinTypers I-IV.",
   "indications_odd": [
    "infemales",
    "skintypers"
   ]
  },
  {
   "id": "K260179",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-06-03",
   "date_received": "2026-01-21",
   "applicant": "Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.",
   "device_name": "VITA Multi-Function Head Brush (TB-2343F, TB-2442F)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260179",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260179.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device. Micro-current function: The micro current stimulation mode is intended for facial stimulation and is indicated for over-the counter cosmetic use."
  },
  {
   "id": "K260715",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-06-03",
   "date_received": "2026-03-05",
   "applicant": "The Beauty Tech Group, Ltd.",
   "device_name": "CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260715",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260715.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The CurrentBody Skin™ LED Multi Light Therapy Mask is an over-the-counter, non-invasive light therapy device. The CurrentBody Skin™ LED Multi Light Therapy Mask delivers visible and near-infrared (NIR) light to the face via non-coherent light-emitting diodes (LEDs). The mask provides four selectable treatment modes: Mode 1 (including red (633nm), NIR (830nm & 1072nm)) is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mode 2 (including blue (415nm) & red (633nm)) is intended for the treatment of mild to moderate inflammatory acne. Mode 3 (including yellow (590nm) & NIR (830nm)) is intended for the treatment of full face wrinkles. The device is intended for use on Fitzpatrick skin types I-IV."
  },
  {
   "id": "K260895",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-05-28",
   "date_received": "2026-03-18",
   "applicant": "Guangxi Ulike Medical Technology Co., Ltd.",
   "device_name": "Ulike Clear Zero (YC10 BU)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260895",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260895.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K261325",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-05-21",
   "date_received": "2026-04-22",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261325",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K261325.pdf",
   "indications": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K260594",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-05-20",
   "date_received": "2026-02-23",
   "applicant": "Shenzhen Xiazhifeng Electronic Co., Ltd.",
   "device_name": "IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260594",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260594.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 7
  },
  {
   "id": "K252591",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-05-13",
   "date_received": "2025-08-15",
   "applicant": "Woorhi Mechatronics Co., Ltd.",
   "device_name": "Automatic Micro Needle System (CODE-X)",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252591",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252591.pdf",
   "indications": "The Automatic Micro Needle System (CODE-X) is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K260415",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-05-12",
   "date_received": "2026-02-09",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "myLEDmask 2 (MJ-144)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260415",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260415.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K252621",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-05-08",
   "date_received": "2025-08-19",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "DeepSkin (DEP100)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252621",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252621.pdf",
   "indications": "The Microcurrent Device (Model: DEP100) is intended for facial stimulation for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K260742",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-05-05",
   "date_received": "2026-03-06",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260742",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260742.pdf",
   "indications": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the long-lasting reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K260150",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-04-22",
   "date_received": "2026-01-20",
   "applicant": "NOOANCE",
   "device_name": "LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "FR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260150",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260150.pdf",
   "indications": "LED Facial Mask (Model: MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C), is intended to emit energy in the red and near-infrared spectrum for treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K260518",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-04-21",
   "date_received": "2026-02-17",
   "applicant": "Shenzhen Semlamp Intelligent Technology Co., Ltd.",
   "device_name": "IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260518",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260518.pdf",
   "indications": "The IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K260202",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-03-23",
   "date_received": "2026-01-23",
   "applicant": "Guangdong Newdermo Biotech Co., Ltd.",
   "device_name": "LED Light Therapy Masks (LumiLips FAC07NA)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260202",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260202.pdf",
   "indications": "The LED Light Therapy Mask is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K254079",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-03-16",
   "date_received": "2025-12-18",
   "applicant": "Shenzhen Desida Technology Co., Ltd.",
   "device_name": "LED Light Therapy Mask (Models: T2, RLD10)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254079",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254079.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K260511",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-03-16",
   "date_received": "2026-02-17",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ulike Reglow Light Therapy Device (UM10)",
   "product_code": "OHS",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260511",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260511.pdf",
   "indications": "Ulike Reglow Light Therapy Device is an Over the Counter device that is intended for the use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K254047",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-03-11",
   "date_received": "2025-12-17",
   "applicant": "Shenzhen Chuangtong Yigou Technology Co., Ltd.",
   "device_name": "Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254047",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254047.pdf",
   "indications": "Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253878",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-03-04",
   "date_received": "2025-12-04",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253878",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253878.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K253874",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-03-03",
   "date_received": "2025-12-04",
   "applicant": "Shenzhen Hanhua Opto Co., Ltd.",
   "device_name": "LED Therapy Light (COB1400, HP1800PRO)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253874",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253874.pdf",
   "indications": "The LED Therapy Light is an over-the-counter (OTC) device intended for the following uses: For Red Mode: The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles. For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of fullface wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253666",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-02-23",
   "date_received": "2025-11-21",
   "applicant": "Shenzhen Mlay Intelligent Technology Co., Ltd.",
   "device_name": "IPL Hair Removal Device (Models: T31A, T32A)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253666",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253666.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253683",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-02-20",
   "date_received": "2025-11-21",
   "applicant": "Foreo, Inc.",
   "device_name": "FAQ™ (LED Panel); FAQ™ (Dual LED Panel)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253683",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253683.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K253002",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-02-19",
   "date_received": "2025-09-19",
   "applicant": "Esthetic Medical, Inc.",
   "device_name": "SkinStylus SteriLock MicroSystem (MP1209SL)",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253002",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253002.pdf",
   "indications": "The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I, II, III, IV, V, and VI in adults aged 34 years or older.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K254007",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-02-12",
   "date_received": "2025-12-15",
   "applicant": "SZ KKS Silicone&Electronic Co., Ltd.",
   "device_name": "LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254007",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254007.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K253833",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-01-30",
   "date_received": "2025-12-01",
   "applicant": "Shenzhen Jianchao Intelligent Technology Co., Ltd.",
   "device_name": "Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253833",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253833.pdf",
   "indications": "Model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808: Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes. (1) The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation. (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. Model: INIA-ED001, INIA-ED002, INIA-BLD001, E1507: Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes. (1) The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation; (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252603",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-01-28",
   "date_received": "2025-08-18",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "HIGHERDOSE Body Sculptor (Model: GS-03)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252603",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252603.pdf",
   "indications": "The HIGHERDOSE BODY SCULPTOR (Model: GS-03) is an over-the-counter device that is intended to improve the appearance of wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253669",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-01-23",
   "date_received": "2025-11-21",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253669",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253669.pdf",
   "indications": "The device are indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253712",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-01-23",
   "date_received": "2025-11-24",
   "applicant": "Shenzhen Rainbow Technology Co., Ltd.",
   "device_name": "LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253712",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253712.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K250341",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2026-01-06",
   "date_received": "2025-02-06",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "Sensilift Pro (ST300XXYYZZZ)",
   "product_code": "PAY",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250341",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250341.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K253881",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-29",
   "date_received": "2025-12-04",
   "applicant": "Shenzhen Fansizhe Science and Technology Co., Ltd.",
   "device_name": "Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253881",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253881.pdf",
   "indications": "Intense Pulsed Light (IPL) System is an over-the-counter device intended for removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253279",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-24",
   "date_received": "2025-09-29",
   "applicant": "Heat IN A Click, LLC",
   "device_name": "Feather/numiere 05 06 07 (05)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253279",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253279.pdf",
   "indications": "Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253349",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-24",
   "date_received": "2025-09-30",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "Hair Regrowth Cap (Model: T-119-HRC)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253349",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253349.pdf",
   "indications": "Hair Regrowth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have NorwoodHamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253400",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-24",
   "date_received": "2025-09-30",
   "applicant": "Shenzhen Saidi Light Therapy Technology Co., Ltd.",
   "device_name": "LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253400",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253400.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K252146",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-23",
   "date_received": "2025-07-09",
   "applicant": "Shenzhen Siken 3D Technology Development Co., Ltd.",
   "device_name": "Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252146",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252146.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K252187",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-23",
   "date_received": "2025-07-14",
   "applicant": "Aura Medical, LLC",
   "device_name": "Aura Glide (FC40)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252187",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252187.pdf",
   "indications": "The Aura Glide is an over-the-counter handheld device for aesthetic purposes. (1) The microcurrent mode is indicated for facial stimulation. (2) The LED mode is intended for the treatment of periorbital wrinkles (red light) and for the treatment of mild to moderate inflammatory acne (blue light).",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253135",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-23",
   "date_received": "2025-09-25",
   "applicant": "Dongguan Yijiaming Technology Co., Ltd.",
   "device_name": "LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253135",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253135.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K253754",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-23",
   "date_received": "2025-11-25",
   "applicant": "Philips Consumer Lifestyle B.V.",
   "device_name": "Philips Lumea IPL",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253754",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253754.pdf",
   "indications": "Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253054",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-19",
   "date_received": "2025-09-22",
   "applicant": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.",
   "device_name": "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253054",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253054.pdf",
   "indications": "The device is an over the counter device that is intended for: Red+Infrared light: Treatment of full-face wrinkles; Red+Blue+Infrared light: Treatment of mild to moderate inflammatory acne; Yellow+Infrared light: Treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253086",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-19",
   "date_received": "2025-09-23",
   "applicant": "Sunglor Technology Co., Ltd.",
   "device_name": "LED Light Therapy Device (Models: SG-FM, SG-FE)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253086",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253086.pdf",
   "indications": "The Led Light Therapy Device (Model: SG-FM) is an Over-the-Counter medical device intended for treatment of wrinkles and mild to moderate inflammatory acne. Red light: Treatment of wrinkles. Red+Infrared Light: Treatment of wrinkles. Amber light: Treatment of wrinkles. Blue Light: Treatment of mild to moderate inflammatory acne. The Led Light Therapy Device (Model: SG-FE) is an Over-the-Counter medical device intended for treatment of wrinkles. Red light: Treatment of wrinkles. Red+Infrared light: Treatment of wrinkles. Infrared light: Provide topical heating for the purpose of elevating tissue temperature, and to temporarily increase local blood circulation.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252983",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-17",
   "date_received": "2025-09-18",
   "applicant": "Shenzhen Goodwind Technology Development Co., Ltd.",
   "device_name": "Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252983",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252983.pdf",
   "indications": "The Wrinkle Retreat Pro Light Therapy Face Mask is an Over-the-Counter (OTC) device intended for use in treating fullface wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252994",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-08",
   "date_received": "2025-09-18",
   "applicant": "Guangdong Ace-Tec Co., Ltd.",
   "device_name": "LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252994",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252994.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K252142",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-12-05",
   "date_received": "2025-07-08",
   "applicant": "Shenzhen Siken 3D Technology Development Co., Ltd.",
   "device_name": "Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252142",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252142.pdf",
   "indications": "Multi-functional Facial Beauty Device (model: SKB-1909): - Blue light is intended for the treatment of facial mild to moderate inflammatory acne. - Red light is intended for the treatment of facial wrinkles. Multi-functional Facial Beauty Device (model: SKB-1703): - Blue light is intended for the treatment of facial mild to moderate inflammatory acne. Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB2209): - Red light is intended for the treatment of facial wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253304",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-11-25",
   "date_received": "2025-09-29",
   "applicant": "Dongguan Lide Electric Appliance Co., Ltd.",
   "device_name": "IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253304",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253304.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K252642",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-11-19",
   "date_received": "2025-08-21",
   "applicant": "Shenzhen Dachi Communication Co., Ltd.",
   "device_name": "Microcurrent Facial Device (CEC101, EEI101)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252642",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252642.pdf",
   "indications": "EC101: Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use. The light treatment of Microcurrent Facial Device is indicated for : - Red light is intended for the treatment of facial wrinkles. - Blue light is intended for the treatment of mild to moderate inflammatory acne. EEI101: Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use. The light treatment of Microcurrent Facial Device is indicated for: - Red light is intended for the treatment of facial wrinkles. - Blue light is intended for the treatment of mild to moderate inflammatory acne. - Mixed light (Red and Blue) is intended for the treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253035",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-11-19",
   "date_received": "2025-09-22",
   "applicant": "Gu'An Yeolight Smart Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal Device (SYL001AZ, SYL002AZ)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253035",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253035.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253073",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-11-19",
   "date_received": "2025-09-23",
   "applicant": "Sunglor Technology Co., Ltd.",
   "device_name": "LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253073",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253073.pdf",
   "indications": "The Led Light Therapy Device (Model:SG-FSM) is an Over-the-Counter medical device intended for treatment of wrinkles in the face and decolletage area. Red light: Treatment of wrinkles. Red+Infrared Light: Treatment of wrinkles. Amber light: Treatment of wrinkles. Amber+Infrared Light: Treatment of wrinkles. The Led Light Therapy Device (Model:SG-NK) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area. Red light: Treatment of wrinkles. Red+Infrared Light: Treatment of wrinkles. Amber light: Treatment of wrinkles. Amber+Infrared Light: Treatment of wrinkles. The Led Light Therapy Device (Model:SG-CT) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area. Red light: Treatment of wrinkles. Red+Infrared light: Treatment of wrinkles. Infrared light: Provide topical heating for the purpose of elevating tissue temperature, and to temporarily increase local blood circulation.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252618",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-11-14",
   "date_received": "2025-08-19",
   "applicant": "Alovea Healthcare Co. , Ltd.",
   "device_name": "IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252618",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252618.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252308",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-11-13",
   "date_received": "2025-07-24",
   "applicant": "Atop Lighting Co., Ltd.",
   "device_name": "LED Beauty Mask (RLBXX)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252308",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252308.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K252414",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-30",
   "date_received": "2025-08-01",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252414",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252414.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 4,
   "indications_withheld": "The Q-Renew LLLT Hair Growth Helmet is indicated for the promotion of hair growth in males who have NorwoodHamilton classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of Ill, and in both, Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K252752",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-30",
   "date_received": "2025-08-29",
   "applicant": "Cytrellis Biosystems, Inc.",
   "device_name": "ellacor System with Micro-Coring Technology",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252752",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252752.pdf",
   "indications": "The ellacor System with Micro-Coring Technology is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. It is further indicated for Fractional Skin Resurfacing.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250618",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-29",
   "date_received": "2025-02-28",
   "applicant": "Ya-Man, Ltd.",
   "device_name": "Medi Lift Essential Eye Mask",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "JP",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250618",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250618.pdf",
   "indications": "The Medi Lift Essential Eye Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K253153",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-29",
   "date_received": "2025-09-26",
   "applicant": "Su-Ko Technologies, LLC",
   "device_name": "SER Pen Carain MicroSystem (MP1209SP)",
   "product_code": "QAI",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253153",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253153.pdf",
   "indications": "The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252053",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-27",
   "date_received": "2025-07-01",
   "applicant": "Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd",
   "device_name": "VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252053",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252053.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 4,
   "indications_withheld": "VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device. Head Mode: The device is indicated to promote hair growth in male with androgenic alopecia who have NorwoodHamilton classifications of IIa-V and females with androgenic aplopecia who have Ludwig-Savin Classification of I-4, II1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV. Face Mode: LED therapy function: The device is indicated for the treatment of full face wrinkles and/or mild to moderate inflammatory acne.",
   "indications_odd": [
    "aplopecia"
   ]
  },
  {
   "id": "K252325",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-22",
   "date_received": "2025-07-25",
   "applicant": "Cosmo Far East Technology Limited",
   "device_name": "Hair Growth Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252325",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252325.pdf",
   "indications": "Hair Growth Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K250227",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-17",
   "date_received": "2025-01-27",
   "applicant": "Shenzhen Qianyu Technology Co., Ltd.",
   "device_name": "JOVS Electric Stimulation Beauty Device (JE2)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250227",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250227.pdf",
   "indications": "JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252264",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-17",
   "date_received": "2025-07-21",
   "applicant": "Shenzhen Zhenxing Ruitong Technology Co., Ltd.",
   "device_name": "MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252264",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252264.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K252093",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-16",
   "date_received": "2025-07-03",
   "applicant": "Merchsource, LLC",
   "device_name": "Light Therapy Mask (1019055)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252093",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252093.pdf",
   "indications": "The Light Therapy Mask is an over-the-counter device intended for the treatment of full-face wrinkles and mild to moderate inflammatory acne using LED light therapy. - Red light: Treatment of full-face wrinkles. - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Infrared Light: Treatment of full-face wrinkles. - Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252234",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-14",
   "date_received": "2025-07-17",
   "applicant": "Shenzhen Qiaochengli Technology Co., Ltd.",
   "device_name": "IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252234",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252234.pdf",
   "indications": "IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242227",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-12",
   "date_received": "2024-07-30",
   "applicant": "Pollogen, Ltd.",
   "device_name": "GENEO X ELITE",
   "product_code": "PAY",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242227",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242227.pdf",
   "indications": null,
   "indications_status": "no document"
  },
  {
   "id": "K251034",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-12",
   "date_received": "2025-04-03",
   "applicant": "Shenzhen Nuon Medical Equipment Co., Ltd.",
   "device_name": "Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251034",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251034.pdf",
   "indications": null,
   "indications_status": "no document"
  },
  {
   "id": "K252209",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-10",
   "date_received": "2025-07-15",
   "applicant": "Foshan Jindi Electric Appliance Co., Ltd.",
   "device_name": "IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252209",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252209.pdf",
   "indications": "IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K252272",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-09",
   "date_received": "2025-07-22",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "ORA Method LED Gua Sha (GS-04)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252272",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252272.pdf",
   "indications": "The ORA Method LED Gua Sha (Model: GS-04) is an Over-the-Counter (OTC) device indicated to emit energy in red and infrared region of the spectrum for treatment of full-face and decolletage wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252553",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-09",
   "date_received": "2025-08-13",
   "applicant": "Shenzhen Jianchao Intelligent Technology Co., Ltd.",
   "device_name": "Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252553",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252553.pdf",
   "indications": "Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes. The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K251398",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-02",
   "date_received": "2025-05-06",
   "applicant": "Shenzhen Enmind Technology Co., Ltd.",
   "device_name": "IPL Hair Removal Device (IPL-001, IPL-002)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251398",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251398.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K251825",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-01",
   "date_received": "2025-06-13",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251825",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251825.pdf",
   "indications": "Jmoon FlexGlow Light Therapy Device is an over the counter device that is intended: - the Red light and Infrared light is indicated for use in the treatment of full face wrinkles, - the Blue light and Red light indicated for the treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252096",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-01",
   "date_received": "2025-07-03",
   "applicant": "Merchsource, LLC",
   "device_name": "Light Therapy Decollete Mask (1019135)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252096",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252096.pdf",
   "indications": "It is an over-the-counter device that is intended for use in the treatment of wrinkles in the decolletage area.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252804",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-10-01",
   "date_received": "2025-09-03",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252804",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252804.pdf",
   "indications": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K251649",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-09-18",
   "date_received": "2025-05-29",
   "applicant": "ShenB Co., Ltd.",
   "device_name": "Sunny Plus (Sunny)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251649",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251649.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K251914",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-09-15",
   "date_received": "2025-06-23",
   "applicant": "Miley Technology (Hebei) Co., Ltd.",
   "device_name": "IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251914",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251914.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 4,
   "indications_withheld": "IPL Hair Removal Device is an over-the counter device intended for removal of unwanted body hair. The device is used for adults with Fitzpatrick skin types 1-IV."
  },
  {
   "id": "K251843",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-09-12",
   "date_received": "2025-06-16",
   "applicant": "Erchonia Corporation",
   "device_name": "Erchonia EVRL",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251843",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251843.pdf",
   "indications": "The Erchonia EVRL is intended to emit energy in the red and blue region of the spectrum, and is specifically indicated to treat mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252189",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-09-12",
   "date_received": "2025-07-14",
   "applicant": "Dongguan Yanxi Technology Co., Ltd.",
   "device_name": "LED Light Therapy Mask (2311, 2344, 2457, 2458)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252189",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252189.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K251781",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-09-04",
   "date_received": "2025-06-11",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "KALA MINI 2.0 (KALA-04)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251781",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251781.pdf",
   "indications": "KALA MINI 2.0 (Model: KALA-04) (Mode 1) is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. KALA MINI 2.0 (Model: KALA-04) (Mode 2) is an over-the counter device intended for the treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K251909",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-09-03",
   "date_received": "2025-06-20",
   "applicant": "A-1 Engineering",
   "device_name": "NeurotriS (SX2500); NeurotriS (SX3800)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251909",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251909.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K243800",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-08-25",
   "date_received": "2024-12-11",
   "applicant": "Dermalogica, LLC",
   "device_name": "PRO Pen Microneedling System (6883)",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243800",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243800.pdf",
   "indications": "The PRO Pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K251588",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-08-21",
   "date_received": "2025-05-23",
   "applicant": "Shenzhen Fittop Health Technology Co., Ltd.",
   "device_name": "LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251588",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251588.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 4,
   "indications_withheld": "The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Overthe-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. FCM902, FCM905, FCM906, FCM908: a.Red light: Treatment of full-face wrinkles. b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne. c.Yellow+Infrared light: Treatment of full-face wrinkles. 11-001-RBMASK: a.Red+Infrared light: Treatment of full-face wrinkles. b.Blue light: Treatment of mild to moderate inflammatory acne. FCM910: a.Red+Infrared light: Treatment of full-face wrinkles. b.Blue light: Treatment of mild to moderate inflammatory acne. c.Yellow+Infrared light: Treatment of full-face wrinkles.",
   "indications_odd": [
    "overthe"
   ]
  },
  {
   "id": "K251871",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-08-15",
   "date_received": "2025-06-18",
   "applicant": "Heat IN A Click, LLC",
   "device_name": "FEATHER 01 02 03 04 (Model:01)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251871",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251871.pdf",
   "indications": "The FEATHER 01 02 03 04 (Model: 01) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the face.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K251012",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-08-14",
   "date_received": "2025-04-02",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "TRUDERMAL Pro (ZLD-390)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251012",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251012.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K251176",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-08-14",
   "date_received": "2025-04-16",
   "applicant": "Shenzhen Mlay Intelligent Technology Co., , Ltd.",
   "device_name": "IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251176",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251176.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K251667",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-08-07",
   "date_received": "2025-05-30",
   "applicant": "Shenzhen Liyoutong Technology Co., Ltd.",
   "device_name": "LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251667",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251667.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K251707",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-08-01",
   "date_received": "2025-06-03",
   "applicant": "Shenzhen Huachuangtong Industrial Co., Ltd.",
   "device_name": "IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251707",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251707.pdf",
   "indications": "IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K251984",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-07-24",
   "date_received": "2025-06-27",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251984",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251984.pdf",
   "indications": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K252218",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-07-18",
   "date_received": "2025-07-15",
   "applicant": "Micro Current Technology, Inc.",
   "device_name": "MF SC GEN2 Facial Toning System",
   "product_code": "NFO",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": true,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252218",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252218.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K251173",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-07-14",
   "date_received": "2025-04-16",
   "applicant": "Shenzhen Fansizhe Science and Technology Co., Ltd.",
   "device_name": "Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251173",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251173.pdf",
   "indications": "The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250761",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-07-11",
   "date_received": "2025-03-13",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "KALA Therapy Wand (Model: KALA-03)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250761",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250761.pdf",
   "indications": "The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250942",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-07-11",
   "date_received": "2025-03-28",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250942",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250942.pdf",
   "indications": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K244004",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-07-10",
   "date_received": "2024-12-26",
   "applicant": "Shenzhen Dachi Communication Co., Ltd.",
   "device_name": "Microcurrent Facial Device (CEC101, EE0101, EEI101)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244004",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K244004.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 4,
   "indications_withheld": "OICEC101 and EE0101: Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use. EEl101: Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use.",
   "indications_odd": [
    "oicec"
   ]
  },
  {
   "id": "K251000",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-06-30",
   "date_received": "2025-04-01",
   "applicant": "Shenzhen Chuangtong Yigou Technology Co., Ltd.",
   "device_name": "Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251000",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251000.pdf",
   "indications": "Hand-held Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K250966",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-06-25",
   "date_received": "2025-03-31",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250966",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250966.pdf",
   "indications": "The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243978",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-06-20",
   "date_received": "2024-12-23",
   "applicant": "Shenzhen Sunsred Technology Co.,Ltd",
   "device_name": "LED Facial Mask",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243978",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243978.pdf",
   "indications": "The LED Facial Mask is an over-the-counter (OTC) device intended for the following uses: For Red Mode(s): The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles. For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of fullface wrinkles. For Blue Mode: The device emits light in the blue region of the spectrum and is specifically indicated for the treatment of mild to moderate acne on the face. For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250880",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-06-20",
   "date_received": "2025-03-24",
   "applicant": "Foshan Guangyu Weilai Medical Equipment Co., Ltd.",
   "device_name": "LED LIGHT MASK (A093)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250880",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250880.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K251017",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-06-17",
   "date_received": "2025-04-02",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251017",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251017.pdf",
   "indications": "The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243036",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-06-15",
   "date_received": "2024-09-27",
   "applicant": "Bestway Plastic and Metal Products , Ltd.",
   "device_name": "IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243036",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243036.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K250830",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-06-09",
   "date_received": "2025-03-19",
   "applicant": "Shenzhen Sungrow Led Technology Co., Ltd.",
   "device_name": "LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250830",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250830.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K251042",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-06-06",
   "date_received": "2025-04-03",
   "applicant": "Guangzhou Ahead Intelligent Technology Co., Ltd.",
   "device_name": "Light Therapy System (M500, L6)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251042",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251042.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K250467",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-06-05",
   "date_received": "2025-02-18",
   "applicant": "Shenzhen Idea Light Limited",
   "device_name": "Red Light Hair Growth Cap (LP-RJVGRW-BLK)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250467",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250467.pdf",
   "indications": "The Red Light Hair Growth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250581",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-05-30",
   "date_received": "2025-02-27",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "KALA Red Light Face Mask (KALA-01)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250581",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250581.pdf",
   "indications": "The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the red and near-infrared spectrum and is intended for the use in the treatment of full-face wrinkles. The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the blue region of the light spectrum and is intended for the use in the treatment of mild to moderate acne vulgaris of the face.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250361",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-05-23",
   "date_received": "2025-02-10",
   "applicant": "Geske Beauty Tech GmbH",
   "device_name": "SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "DE",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250361",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250361.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K250384",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-05-23",
   "date_received": "2025-02-11",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "IPL400",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250384",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250384.pdf",
   "indications": "IPL400 device is indicated for the removal of unwanted hair. The device is also indicated for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of the treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250938",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-05-23",
   "date_received": "2025-03-28",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250938",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250938.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. Shenzhen Ulike Smart Electronics Co., Ltd."
  },
  {
   "id": "K250532",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-05-22",
   "date_received": "2025-02-24",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "Solawave 2-in-1 Skincare Mini (Model: 61043)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250532",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250532.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K243017",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-05-06",
   "date_received": "2024-09-27",
   "applicant": "Foshan Newface Electronic Technology Co., Ltd.",
   "device_name": "IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243017",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243017.pdf",
   "indications": null,
   "indications_status": "no document"
  },
  {
   "id": "K250253",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-05-06",
   "date_received": "2025-01-28",
   "applicant": "Dongguan Boyuan Intelligent Technology Co.,Ltd",
   "device_name": "IPL Hair Removal Device (KCA511/KCA516/KCA522)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250253",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250253.pdf",
   "indications": "IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K244020",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-05-01",
   "date_received": "2024-12-27",
   "applicant": "Shenzhen Qianyu Technology Co., Ltd.",
   "device_name": "Wrinkle Treatment Device (JM1, JM2B)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244020",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K244020.pdf",
   "indications": "The Wrinkle Treatment Device is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250308",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-04-29",
   "date_received": "2025-02-03",
   "applicant": "Dongguan Boyuan Intelligent Technology Co.,Ltd",
   "device_name": "Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250308",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250308.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 4,
   "indications_withheld": "Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with and rogenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_odd": [
    "rogenetic"
   ]
  },
  {
   "id": "K242151",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-04-08",
   "date_received": "2024-07-23",
   "applicant": "Shenzhen Nuon Medical Equipment Co., Ltd.",
   "device_name": "Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242151",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242151.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The Radiant Renewal Skincare Wand (Models: HD-44, HD-44A, HD-44B, HD-69, HD-69A) is an over-thecounter device intended for the treatment of full-face wrinkles. The Radiant Renewal Skincare Wand (Models: HD-44C, HD-69B) is an over-the-counter device intended for the treatment of the mild to moderate inflammatory acne."
  },
  {
   "id": "K242385",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-04-07",
   "date_received": "2024-08-12",
   "applicant": "Shenzhen Borria Technology Co., Ltd.",
   "device_name": "LED Therapy Mask (MN1, M226)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242385",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242385.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K243143",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-04-07",
   "date_received": "2024-09-30",
   "applicant": "Bomtech Electronics Co., Ltd.",
   "device_name": "E-PEN (E-PEN)",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243143",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243143.pdf",
   "indications": "The E-PEN is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242068",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-04-04",
   "date_received": "2024-07-15",
   "applicant": "Ningbo Dechang Electrical Machinery Made Co.,Ltd",
   "device_name": "LED Light Therapy Mask (RT01)",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242068",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242068.pdf",
   "indications": "The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and Near Infrared spectrum and is intended for the use in the treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 7
  },
  {
   "id": "K243072",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-04-01",
   "date_received": "2024-09-27",
   "applicant": "EMA Aesthetics , Ltd.",
   "device_name": "Préime DermaFacial (MicroT)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "IE",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243072",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243072.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K250194",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-03-26",
   "date_received": "2025-01-23",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250194",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250194.pdf",
   "indications": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K250125",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-03-24",
   "date_received": "2025-01-17",
   "applicant": "Xplr , Ltd.",
   "device_name": "LMNT O2",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250125",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250125.pdf",
   "indications": "LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243472",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-03-19",
   "date_received": "2024-11-08",
   "applicant": "Campomats S.R.L.",
   "device_name": "1NEED Pro",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IT",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243472",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243472.pdf",
   "indications": "The 1NEED Pro is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250131",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-03-19",
   "date_received": "2025-01-17",
   "applicant": "Mustech Electronics Co., Limited",
   "device_name": "IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250131",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250131.pdf",
   "indications": "IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250171",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-03-19",
   "date_received": "2025-01-21",
   "applicant": "Shenzhen Yang WO Electronic Co., Ltd.",
   "device_name": "IPL Hair Removal Device (BE965A, BE965B, BE965C)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250171",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250171.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K250413",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-03-18",
   "date_received": "2025-02-13",
   "applicant": "Shenzhen Perfect Idea Technology Limited",
   "device_name": "Aglaia LED Beauty Device (BP-D2309)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250413",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250413.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K241790",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-03-06",
   "date_received": "2024-06-21",
   "applicant": "Dermaroller GmbH",
   "device_name": "XCELLARISPRO TWIST microneedling device",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "DE",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241790",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241790.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types 1, 11, 111 and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types 1, 11 and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older."
  },
  {
   "id": "K243587",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-03-06",
   "date_received": "2024-11-20",
   "applicant": "Xtreem Pulse, LLC",
   "device_name": "PureLift GLOW",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243587",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243587.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "PureLift GLOW is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use."
  },
  {
   "id": "K241947",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-03-03",
   "date_received": "2024-07-03",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "EnergyLounger (TY-01)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241947",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241947.pdf",
   "indications": "M1 is used to reduce the circumference of the hips, waist and thighs and is indicated for use as a noninvasive dermatological. M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles. M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243330",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-02-21",
   "date_received": "2024-10-24",
   "applicant": "Lyma Life , Ltd.",
   "device_name": "LYMA Laser PRO",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243330",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243330.pdf",
   "indications": "The LYMA Laser PRO is an Over-the-Counter (OTC) light based device intended for the use in treating face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242593",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-02-14",
   "date_received": "2024-08-30",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242593",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242593.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K243063",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-02-10",
   "date_received": "2024-09-27",
   "applicant": "Raja Trading Company, Inc.",
   "device_name": "Myolight Microcurrent Handpiece",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243063",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243063.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation."
  },
  {
   "id": "K243453",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-02-10",
   "date_received": "2024-11-07",
   "applicant": "Philips Consumer Lifestyle B.V.",
   "device_name": "Philips Lumea IPL",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243453",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243453.pdf",
   "indications": "Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243555",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-02-05",
   "date_received": "2024-11-18",
   "applicant": "Shenzhen Eyco Technology Co., Ltd.",
   "device_name": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243555",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243555.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K243393",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-02-03",
   "date_received": "2024-10-31",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243393",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243393.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for overthe-counter cosmetic use. JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles."
  },
  {
   "id": "K243423",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-01-28",
   "date_received": "2024-11-04",
   "applicant": "Shenzhen Rainbow Technology Co., Ltd.",
   "device_name": "LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243423",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243423.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K244048",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-01-16",
   "date_received": "2024-12-31",
   "applicant": "Ya-Man, Ltd.",
   "device_name": "Medi Lift Mask",
   "product_code": "NFO",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "JP",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K244048",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K244048.pdf",
   "indications": "The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243492",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-01-10",
   "date_received": "2024-11-12",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ulike Reglow Light Therapy Device (UM10)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243492",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243492.pdf",
   "indications": "Ulike Reglow Light Therapy Device is an over the counter device that is intended for use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242789",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2025-01-02",
   "date_received": "2024-09-16",
   "applicant": "Dongguan Laiguang Electronic Technology Co., Ltd.",
   "device_name": "Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242789",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242789.pdf",
   "indications": "This device produces light in the blue light (415nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The red light (635nm) in combination with near-infrared light (850nm) is intended to improve the appearance of wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243085",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-12-21",
   "date_received": "2024-09-30",
   "applicant": "Zhuzhou Goldenhot Medical Technology Co., Ltd.",
   "device_name": "IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243085",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243085.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243040",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-12-20",
   "date_received": "2024-09-27",
   "applicant": "Shenzhen Siken 3D Technology Development Co., Ltd.",
   "device_name": "LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243040",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243040.pdf",
   "indications": "LED Light Therapy Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242700",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-12-19",
   "date_received": "2024-09-09",
   "applicant": "Shenzhen Nuon Medical Equipment Co., Ltd.",
   "device_name": "Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242700",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242700.pdf",
   "indications": "The Radiant Renewal Skincare Lid (Model: HD-59A, HD-59B, HD-72, HD-73A, HD-116, HD-53A) is intended for the treatment of wrinkles for over-the-counter cosmetic use. The Radiant Renewal Skincare Lid (Model: HD-70) is intended for the treatment of wrinkles and the mild to moderate inflammatory acne for over-the-counter cosmetic use. The Radiant Renewal Skincare Lid (Model: HD-59D, HD-72A, HD-73B,HD-116A,HD-53B) is intended for the treatment of the mild to moderate inflammatory acne for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243430",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-12-19",
   "date_received": "2024-11-05",
   "applicant": "Shenzhen Aozemei Technology Co., Ltd.",
   "device_name": "Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243430",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243430.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K241998",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-12-13",
   "date_received": "2024-07-09",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241998",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241998.pdf",
   "indications": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242532",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-12-13",
   "date_received": "2024-08-26",
   "applicant": "BTL Industries, Inc.",
   "device_name": "BTL-785BNF-E",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242532",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242532.pdf",
   "indications": "The BTL-785BNF-E device has the following indications for use: The device is indicated for aesthetic use including facial and neck or body skin stimulation.",
   "indications_status": "quoted",
   "indications_page": 7
  },
  {
   "id": "K242747",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-12-11",
   "date_received": "2024-09-12",
   "applicant": "Foreo, Inc.",
   "device_name": "FAQ™ (302)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242747",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242747.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 4,
   "indications_withheld": "FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of l-II and Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K242710",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-12-06",
   "date_received": "2024-09-09",
   "applicant": "Shenzhen Jianchao Intelligent Technology Co., Ltd.",
   "device_name": "Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242710",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242710.pdf",
   "indications": "Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242619",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-12-02",
   "date_received": "2024-09-03",
   "applicant": "Apira Science, Inc.",
   "device_name": "GroWell BT Hair Growth System (GW10042)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242619",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242619.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K242638",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-11-27",
   "date_received": "2024-09-03",
   "applicant": "Shenzhen Walton Technology Co., Ltd.",
   "device_name": "LED Light Therapy Machine (G1, G3, G4, G6)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242638",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242638.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K242796",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-11-27",
   "date_received": "2024-09-16",
   "applicant": "Sharkninja Operating, LLC",
   "device_name": "CryoGlow (FW3XXXX)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242796",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242796.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K243362",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-11-27",
   "date_received": "2024-10-29",
   "applicant": "Cyden Limited",
   "device_name": "SmoothSkin Pure Switch (SSC1)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243362",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243362.pdf",
   "indications": "The SmoothSkin Pure Switch is intended for the removal of unwanted hair. The SmoothSkin Pure Switch is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242363",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-11-20",
   "date_received": "2024-08-09",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "HIGHERDOSE Red Light Hat (HG-120K)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242363",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242363.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K241342",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-11-08",
   "date_received": "2024-05-13",
   "applicant": "Shenzhen Nuon Medical Equipment Co., Ltd.",
   "device_name": "Hair Growth Comb (SZ-23,SZ-23A)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241342",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241342.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The Hair Growth Comb (Model: SZ-23 ,SZ-23A,) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV."
  },
  {
   "id": "K242382",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-11-08",
   "date_received": "2024-08-12",
   "applicant": "iSMART Developments, Ltd.",
   "device_name": "décoLITE LED Device",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242382",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242382.pdf",
   "indications": "The décoLITE LED device is an over-the-counter device that is intended for the use in the treatment of wrinkles in the decolletage area.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242595",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-11-07",
   "date_received": "2024-08-30",
   "applicant": "Shenzhen Greatro Electronic Technology Co., Ltd.",
   "device_name": "Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242595",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242595.pdf",
   "indications": "Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K242039",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-11-06",
   "date_received": "2024-07-12",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242039",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242039.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K242620",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-11-01",
   "date_received": "2024-09-03",
   "applicant": "Shenzhen Breo Technology Co., Ltd.",
   "device_name": "Breo Laser Hair Growth Comb (Scalp 3L)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242620",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242620.pdf",
   "indications": "Breo Laser Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K241718",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-10-28",
   "date_received": "2024-06-14",
   "applicant": "Shenzhen Aozemei Technology Co., Ltd.",
   "device_name": "Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241718",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241718.pdf",
   "indications": "Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K243030",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-10-25",
   "date_received": "2024-09-27",
   "applicant": "Ulike Co., Ltd.",
   "device_name": "Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243030",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243030.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K242197",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-10-17",
   "date_received": "2024-07-26",
   "applicant": "Shenzhen Huaruibo Electric Appliances Co., Ltd.",
   "device_name": "IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242197",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242197.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K240472",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-10-11",
   "date_received": "2024-02-20",
   "applicant": "Dongguan Tutamen Metalwork Co., Ltd.",
   "device_name": "PBM Hair Therapy Cap",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240472",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240472.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K241857",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-10-11",
   "date_received": "2024-06-27",
   "applicant": "Dongguan Boyuan Intelligent Technology Co.,Ltd",
   "device_name": "LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241857",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241857.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K241355",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-10-09",
   "date_received": "2024-05-14",
   "applicant": "Su-Ko Technologies, LLC",
   "device_name": "SER Pen Carain MicroSystem (MP1209SP)",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241355",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241355.pdf",
   "indications": "The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K241933",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-09-27",
   "date_received": "2024-07-02",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "HIGHERDOSE Red and Infrared Light Mask (MK66-L)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241933",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241933.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles."
  },
  {
   "id": "K241834",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-09-23",
   "date_received": "2024-06-25",
   "applicant": "Shenzhen Yang WO Electronic Co., Ltd.",
   "device_name": "IPL Hair Removal Device (BE932C, BE932D, BE932E)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241834",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241834.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair."
  },
  {
   "id": "K240689",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-09-17",
   "date_received": "2024-03-13",
   "applicant": "Telebrands Corporation",
   "device_name": "Robin's Egg",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240689",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240689.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 4,
   "indications_withheld": "The Robin's Egg is indicated to treat Androgenetic Alopecia and promote hair growth in males who have NorwoodHamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-I to I-4, II-I, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV."
  },
  {
   "id": "K242441",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-09-13",
   "date_received": "2024-08-16",
   "applicant": "Revian, Inc.",
   "device_name": "Revian Lyte (10011)",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242441",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242441.pdf",
   "indications": "Revian Lyte is intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I to IV.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K241205",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-09-09",
   "date_received": "2024-04-30",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241205",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241205.pdf",
   "indications": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K241400",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-08-29",
   "date_received": "2024-05-17",
   "applicant": "Crown Aesthetics",
   "device_name": "SkinPen Precision Elite System",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241400",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241400.pdf",
   "indications": "The SkinPen® Precision Elite System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K241881",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-08-29",
   "date_received": "2024-06-28",
   "applicant": "Shenzhen Junmei Technology Co., Ltd.",
   "device_name": "IPL Hair Removal Device (JM-843, JM-865, JM-638)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241881",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241881.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K241102",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-08-20",
   "date_received": "2024-04-22",
   "applicant": "Foreo, Inc.",
   "device_name": "Luna 4 plus",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241102",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241102.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K241203",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-07-25",
   "date_received": "2024-04-30",
   "applicant": "Dongguan Hunter Electronic Technology Co., Ltd.",
   "device_name": "PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241203",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241203.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K240616",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-07-15",
   "date_received": "2024-03-05",
   "applicant": "Foreo, Inc.",
   "device_name": "FAQ™ (102)",
   "product_code": "PAY",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240616",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240616.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K240016",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-07-10",
   "date_received": "2024-01-02",
   "applicant": "Shenzhen Jianrong Biomedical Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal Device (YT01,YT02,YT03,YT04)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240016",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240016.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K241343",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-07-09",
   "date_received": "2024-05-13",
   "applicant": "Shenzhen Lescolton Electrical Appliance Co., Ltd.",
   "device_name": "IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241343",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241343.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K240564",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-06-27",
   "date_received": "2024-02-29",
   "applicant": "Carol Cole Company Dba Nuface®",
   "device_name": "NuFACE® FIX+",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240564",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240564.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The NuFACE FIX+ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use."
  },
  {
   "id": "K241120",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-06-24",
   "date_received": "2024-04-23",
   "applicant": "Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.",
   "device_name": "Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241120",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241120.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "Intense pulsed light therapy apparatus is an over-the-counter device intended for removal of unwanted body and/or facial hair."
  },
  {
   "id": "K240649",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-06-21",
   "date_received": "2024-03-07",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240649",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240649.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K240583",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-06-18",
   "date_received": "2024-03-01",
   "applicant": "Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.",
   "device_name": "IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240583",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240583.pdf",
   "indications": "IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K240969",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-05-31",
   "date_received": "2024-04-09",
   "applicant": "Shenzhen Semlamp Intelligent Technology Co., Ltd.",
   "device_name": "IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240969",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240969.pdf",
   "indications": "The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K240456",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-05-22",
   "date_received": "2024-02-15",
   "applicant": "Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC",
   "device_name": "Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240456",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240456.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 4,
   "indications_withheld": "The Bosley Booster 128 Laser Cap, Bosley Booster 162 Laser Cap, and Bosley Booster 288 Laser Cap are indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV."
  },
  {
   "id": "K241106",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-05-22",
   "date_received": "2024-04-22",
   "applicant": "Shenzhen Mlay Intelligent Technology Co., , Ltd.",
   "device_name": "Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241106",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241106.pdf",
   "indications": "The Ice Cooling IPL Home Use Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232242",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-05-13",
   "date_received": "2023-07-28",
   "applicant": "Foreo, Inc.",
   "device_name": "BEAR 2 Body",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232242",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232242.pdf",
   "indications": "The device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K233766",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-05-07",
   "date_received": "2023-11-24",
   "applicant": "Pollogen, Ltd.",
   "device_name": "Geneo X Elite",
   "product_code": "PAY",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233766",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233766.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The GENEO X ELITE system with the TriPollar RF Applicator is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV. The GENEO X ELITE system with the OxyGeneo Applicator is intended to provide massage by a mechanical vibration of an electrically powered applicator. The OxyGeneo treatment is suitable for all skin types."
  },
  {
   "id": "K240093",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-04-24",
   "date_received": "2024-01-12",
   "applicant": "Shenzhen Shuge Medical Beauty Devices Co., Ltd.",
   "device_name": "IPL Home Use Hair Removal Device (SJ15)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240093",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240093.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 6,
   "indications_withheld": "IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K240378",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-04-19",
   "date_received": "2024-02-07",
   "applicant": "Foreo, Inc.",
   "device_name": "FAQ™ 201, FAQ™ 202",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240378",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240378.pdf",
   "indications": "FAQ™ 201 and 202 devices are intended to use LED light for the treatment of wrinkles and mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K240089",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-04-10",
   "date_received": "2024-01-12",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "Face Patches (MT-12MA, MT-12MC)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240089",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240089.pdf",
   "indications": "Face Patches (Model: MT-12MA) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne. Face Patches (Model: MT-12MC) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne and full-face wrinkles (including periorbital wrinkles).",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K240360",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-04-05",
   "date_received": "2024-02-06",
   "applicant": "Shenzhen Qianyu Technology Co., Ltd.",
   "device_name": "Wrinkle Treatment Device (JM2)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240360",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240360.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The wrinkle treatment device (model: JM2) is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles."
  },
  {
   "id": "K240652",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-04-04",
   "date_received": "2024-03-07",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240652",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240652.pdf",
   "indications": "Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K240282",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-04-03",
   "date_received": "2024-02-01",
   "applicant": "Dongguan Boyuan Intelligent Technology Co.,Ltd",
   "device_name": "IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240282",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240282.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K240587",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-03-29",
   "date_received": "2024-03-01",
   "applicant": "Cyden Limited",
   "device_name": "SmoothSkin Pure Unplugged (SSB3)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240587",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240587.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The SmoothSkin Pure Unplugged is intended for the removal of unwanted hair. The SmoothSkin Pure Unplugged is also indicated for the permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K240264",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-03-08",
   "date_received": "2024-01-31",
   "applicant": "Shenzhen Mlay Intelligent Technology Co., , Ltd.",
   "device_name": "Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240264",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240264.pdf",
   "indications": "The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232424",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-03-06",
   "date_received": "2023-08-11",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "CurrentBody Skin RF",
   "product_code": "PAY",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232424",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232424.pdf",
   "indications": "The CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K233862",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-03-01",
   "date_received": "2023-12-06",
   "applicant": "Premier North America, Inc.",
   "device_name": "NUNA LUX (NUNL528)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233862",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233862.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K233709",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-02-23",
   "date_received": "2023-11-20",
   "applicant": "Mt. Derm GmbH",
   "device_name": "Exceed Unlimited",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "DE",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233709",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233709.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I, II and/or Ill in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older. The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, Ill and IV in adults aged 22 years or older."
  },
  {
   "id": "K233667",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-02-12",
   "date_received": "2023-11-15",
   "applicant": "Body Trim Industrial Co., Ltd.",
   "device_name": "Facial Toning device (UIC-189); Facial Toning device (UIC-589)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "TW",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233667",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233667.pdf",
   "indications": "The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K240064",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-02-07",
   "date_received": "2024-01-09",
   "applicant": "Wontech Co., Ltd.",
   "device_name": "Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240064",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240064.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 4,
   "indications_withheld": "The Hair Boom Air is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications ofl - II, males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K233887",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-01-22",
   "date_received": "2023-12-08",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233887",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233887.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K233114",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-01-12",
   "date_received": "2023-09-27",
   "applicant": "Shenzhen Idea Light Limited",
   "device_name": "LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233114",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233114.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 4,
   "indications_withheld": "LED silicone mask (Models: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) is an over-thecounter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. LED silicone mask (Models: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) is an over-thecounter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.",
   "indications_odd": [
    "thecounter"
   ]
  },
  {
   "id": "K233664",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-01-11",
   "date_received": "2023-11-15",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233664",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233664.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K233679",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-01-05",
   "date_received": "2023-11-16",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233679",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233679.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K233556",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2024-01-04",
   "date_received": "2023-11-06",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "LED Eye mask (EY-20R, A20, EY-20N)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233556",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233556.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The LED Eye mask (Model: EY-20R, 20A, EY-20N) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region."
  },
  {
   "id": "K233782",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-12-20",
   "date_received": "2023-11-27",
   "applicant": "Cyden Limited",
   "device_name": "SmoothSkin Pure Adapt (SSG3)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233782",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233782.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The SmoothSkin Pure Adapt is intended for the removal of unwanted hair. The SmoothSkin Pure Adapt is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K232939",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-12-15",
   "date_received": "2023-09-20",
   "applicant": "Shenzhen Borria Technology Co., Ltd.",
   "device_name": "IPL Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232939",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232939.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The IPL Hair Removal Device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232863",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-12-13",
   "date_received": "2023-09-15",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "Radiant Renewal Skincare Wand (HD-15, HD-15A)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232863",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232863.pdf",
   "indications": "The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use. The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232795",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-12-07",
   "date_received": "2023-09-12",
   "applicant": "Stg24 Co., Ltd.",
   "device_name": "Led Mask Platinum Exclusive MD",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232795",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232795.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "LED MASK EXCLUSIVE MD is an over the counter device that is indicated for the treatment of full face wrinkles with red light and infrared light and treat mild to moderate acne vulgaris of the face."
  },
  {
   "id": "K232846",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-12-07",
   "date_received": "2023-09-14",
   "applicant": "Shenzhen Meik Beauty Industry Co., Ltd.",
   "device_name": "Light Based Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232846",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232846.pdf",
   "indications": "Light Based Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232932",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-12-04",
   "date_received": "2023-09-20",
   "applicant": "Shenzhen Greatro Electronic Technology Co., Ltd.",
   "device_name": "Intense Pulse Light Therapeutic Apparatus",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232932",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232932.pdf",
   "indications": "Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K233525",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-11-24",
   "date_received": "2023-11-01",
   "applicant": "Micro Current Technology, Inc.",
   "device_name": "MF SC Facial Toning System",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": true,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233525",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233525.pdf",
   "indications": "The MF SC Facial Toning System is intended to stimulate the face. The device is indicated for over the counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232001",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-11-21",
   "date_received": "2023-07-05",
   "applicant": "Nse Products, Inc.",
   "device_name": "Nu Skin RenuSpa iO",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232001",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232001.pdf",
   "indications": "Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K233010",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-11-21",
   "date_received": "2023-09-22",
   "applicant": "Belega, Inc.",
   "device_name": "Beagank 4T Plus",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "JP",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233010",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233010.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K232575",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-11-20",
   "date_received": "2023-08-25",
   "applicant": "Shenzhen Jianchao Intelligent Technology Co., Ltd.",
   "device_name": "Hair Removal Device, Model(s): R2815-G Pro, R2815-G",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232575",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232575.pdf",
   "indications": "Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232656",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-11-14",
   "date_received": "2023-08-31",
   "applicant": "Premier North America, Inc.",
   "device_name": "BLU TOTALE (Model: ENEOB852)",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232656",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232656.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K232845",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-11-14",
   "date_received": "2023-09-14",
   "applicant": "Shenzhen Siken 3D Technology Development Co., Ltd.",
   "device_name": "IPL Cooling Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232845",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232845.pdf",
   "indications": "IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K230490",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-10-27",
   "date_received": "2023-02-23",
   "applicant": "Dongguan Hunter Electronic Technology Co., Ltd.",
   "device_name": "PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230490",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230490.pdf",
   "indications": "The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232356",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-10-24",
   "date_received": "2023-08-07",
   "applicant": "Hubei Yjt Technology Co.,Ltd",
   "device_name": "Laser Cap, Model: Hat-01",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232356",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232356.pdf",
   "indications": "Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Skin Phototypes I-IV.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K230459",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-10-19",
   "date_received": "2023-02-21",
   "applicant": "21 Equipment S.R.L.",
   "device_name": "C.C. Life 21",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "IT",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230459",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230459.pdf",
   "indications": "The C.C.Life 21 device with C-Life handle (RF) is indicated for the temporary relief of minor muscle aches and pain temporary relief of muscle spasm, and temporary improvement of local blood circulation. The C.C.Life 21 device with C-Life Micro handle (TENS) is intended for facial stimulation and is indicated for cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232499",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-10-11",
   "date_received": "2023-08-17",
   "applicant": "Shenzhen Lescolton Electrical Appliance Co., Ltd.",
   "device_name": "IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232499",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232499.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232056",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-10-06",
   "date_received": "2023-07-11",
   "applicant": "Dongguan Lide Electric Appliance Co., Ltd.",
   "device_name": "IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232056",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232056.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K232274",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-09-28",
   "date_received": "2023-07-31",
   "applicant": "Lumenessa Corp",
   "device_name": "IPL hair removal device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232274",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232274.pdf",
   "indications": "The product is an over-the-counter device intended for removal of unwanted body and facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K231977",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-09-25",
   "date_received": "2023-07-03",
   "applicant": "Foreo, Inc.",
   "device_name": "PEACH 2, PEACH 2 Duo, PEACH 2 go",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231977",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231977.pdf",
   "indications": "PEACH 2, PEACH 2 Duo and PEACH 2 Go are over-the-counter device intended for the removal of unwanted body hair and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K223919",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-09-23",
   "date_received": "2022-12-29",
   "applicant": "Bemer Int AG",
   "device_name": "B.Light Clear Evo and B.Light Restore Evo",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "LI",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223919",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223919.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K232183",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-09-22",
   "date_received": "2023-07-24",
   "applicant": "Shenzhen Koli Technology Co.,Ltd",
   "device_name": "IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232183",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232183.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K232172",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-09-18",
   "date_received": "2023-07-21",
   "applicant": "BTL Industries, Inc.",
   "device_name": "BTL-785BNF Handpiece",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232172",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232172.pdf",
   "indications": "The BTL-785BNF Handpiece device has the following indications for use: The device is indicated for aesthetic use including facial and neck stimulation or body skin stimulation.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K232124",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-09-14",
   "date_received": "2023-07-17",
   "applicant": "Shenzhen Wochuan Electronic Co., Ltd.",
   "device_name": "IPL Hair Removal, Model: W-1095, W-1098",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232124",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232124.pdf",
   "indications": "IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230362",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-09-11",
   "date_received": "2023-02-10",
   "applicant": "Shenzhen Leaflife Technology Co., Ltd.",
   "device_name": "Planar LED mate",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230362",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230362.pdf",
   "indications": "The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K231800",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-09-07",
   "date_received": "2023-06-20",
   "applicant": "Shenzhen Qianyu Technology Co., Ltd.",
   "device_name": "IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231800",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231800.pdf",
   "indications": "IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K231717",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-09-06",
   "date_received": "2023-06-13",
   "applicant": "Foshan Jindi Electric Appliance Co., Ltd.",
   "device_name": "IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231717",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231717.pdf",
   "indications": "IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230013",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-08-30",
   "date_received": "2023-01-03",
   "applicant": "Silk'N Beauty , Ltd.",
   "device_name": "Silk'n Titan Allways",
   "product_code": "PAY",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230013",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230013.pdf",
   "indications": "The Silk’n Titan AllWays is an over-the-counter home use device intended for the non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick skin types I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230420",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-08-11",
   "date_received": "2023-02-16",
   "applicant": "Guangzhou Ekai Electronic Technology Co., Ltd.",
   "device_name": "Dr. pen Microneedling System",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230420",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230420.pdf",
   "indications": "The Dr.pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K231321",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-07-31",
   "date_received": "2023-05-08",
   "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.",
   "device_name": "Nooance Led And Laser Helmet",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231321",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231321.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 3,
   "indications_withheld": "The NOOĀNCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have HamiltonNorwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of l-II and Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_odd": [
    "hamiltonnorwood"
   ]
  },
  {
   "id": "K231613",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-07-31",
   "date_received": "2023-06-02",
   "applicant": "Zhuzhou Goldenhot Medical Technology Co., Ltd.",
   "device_name": "Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231613",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231613.pdf",
   "indications": "The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K231073",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-07-28",
   "date_received": "2023-04-14",
   "applicant": "Esthetic Medical, Inc.",
   "device_name": "SkinStylus SteriLock® MicroSystem, Model Number MP1209SL",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231073",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231073.pdf",
   "indications": "The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K231555",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-07-27",
   "date_received": "2023-05-30",
   "applicant": "iSMART Developments, Ltd.",
   "device_name": "LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231555",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231555.pdf",
   "indications": "The LUMA LED light patches are over-the-counter devices intended to emit energy in the visible and near infra-red light spectrum. LUMA Blemish is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. LUMA Revive is an over-the-counter device intended to emit energy in the red and Near infra-red spectrum and is intended for the use in the treatment of facial wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230025",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-07-03",
   "date_received": "2023-01-04",
   "applicant": "Ivylaser (Beijing) Technology Co.,Ltd",
   "device_name": "IVYLASER Handhold Hair Removal Machine",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230025",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230025.pdf",
   "indications": "IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent hair reduction defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime .",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230720",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-07-03",
   "date_received": "2023-03-16",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230720",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230720.pdf",
   "indications": "The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K220198",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-06-28",
   "date_received": "2022-01-24",
   "applicant": "Ya-Man, Ltd.",
   "device_name": "Medi Lift PLUS",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "JP",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220198",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220198.pdf",
   "indications": "The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K231215",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-06-26",
   "date_received": "2023-04-28",
   "applicant": "Zhongshan Qizhe Technology Co., Ltd.",
   "device_name": "IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231215",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231215.pdf",
   "indications": "The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K231153",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-06-23",
   "date_received": "2023-04-24",
   "applicant": "Nature, Inc.redible, Inc.",
   "device_name": "Neuhat Hair Growth System; ibeauty.com Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231153",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231153.pdf",
   "indications": "Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have NorwoodHamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV. ibeauty.com Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have NorwoodHamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230506",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-06-21",
   "date_received": "2023-02-24",
   "applicant": "Xtreem Pulse",
   "device_name": "PureLift Pro Edition",
   "product_code": "NFO",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230506",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230506.pdf",
   "indications": "Intended for facial stimulation and indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230473",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-06-15",
   "date_received": "2023-02-22",
   "applicant": "Miley Technology (Hebei) Co., Ltd.",
   "device_name": "IPL Hair Removal Device Models: MLY-T069",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230473",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230473.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K222790",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-06-14",
   "date_received": "2022-09-15",
   "applicant": "Lumenis Be, Ltd.",
   "device_name": "F65 Laser System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222790",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222790.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K230293",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-06-09",
   "date_received": "2023-02-02",
   "applicant": "Therabody, Inc.",
   "device_name": "TheraFace Mask",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230293",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230293.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K230739",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-05-26",
   "date_received": "2023-03-17",
   "applicant": "Shenzhen Ionka Medical Technology Co., Ltd.",
   "device_name": "Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230739",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230739.pdf",
   "indications": "Hand-held IPL device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230134",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-05-23",
   "date_received": "2023-01-17",
   "applicant": "Hubei Yjt Technology Co.,Ltd",
   "device_name": "Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230134",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230134.pdf",
   "indications": "Laser Therapy Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K223893",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-05-16",
   "date_received": "2022-12-28",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "Infrared Heat (Model: E0221)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223893",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223893.pdf",
   "indications": "The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K223147",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-05-14",
   "date_received": "2022-10-05",
   "applicant": "Myblend",
   "device_name": "myLEDmask",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "FR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223147",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223147.pdf",
   "indications": "MyLedMask is an over-the-counter device that is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K230351",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-05-05",
   "date_received": "2023-02-09",
   "applicant": "Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.",
   "device_name": "LED Facial Mask",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230351",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230351.pdf",
   "indications": "LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K220322",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-05-04",
   "date_received": "2022-02-03",
   "applicant": "Pollogen, Ltd.",
   "device_name": "Pollogen STOP U Model UXV Device",
   "product_code": "PAY",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220322",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220322.pdf",
   "indications": "The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K223862",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-28",
   "date_received": "2022-12-23",
   "applicant": "Wontech Co., Ltd.",
   "device_name": "Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223862",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223862.pdf",
   "indications": "The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230042",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-28",
   "date_received": "2023-01-06",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "Q-Rejuvalight Pro Facewear (Model: P19-0023)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230042",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230042.pdf",
   "indications": "The Q-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230597",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-28",
   "date_received": "2023-03-03",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230597",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230597.pdf",
   "indications": "The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K213078",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-27",
   "date_received": "2021-09-23",
   "applicant": "Johari Digital Healthcare Limited",
   "device_name": "Myolift QT",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213078",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213078.pdf",
   "indications": "“Myolift QT” is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230911",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-27",
   "date_received": "2023-03-31",
   "applicant": "Cyden Limited",
   "device_name": "Braun Skin i.expert",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230911",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230911.pdf",
   "indications": "The Braun Skin i.expert Hair Removal Device is indicated for the removal of unwanted hair. The Braun Skin i.expert is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230549",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-25",
   "date_received": "2023-02-28",
   "applicant": "Shenzhen Xiazhifeng Electronic Co., Ltd.",
   "device_name": "IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230549",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230549.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230090",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-19",
   "date_received": "2023-01-12",
   "applicant": "Wuhan Lotuxs Technology Co., Ltd.",
   "device_name": "Diode Laser Hair Removal",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230090",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230090.pdf",
   "indications": "Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230122",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-10",
   "date_received": "2023-01-17",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230122",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230122.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230360",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-10",
   "date_received": "2023-02-10",
   "applicant": "Shenzhen Jizhimei Technology Co., Ltd.",
   "device_name": "IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230360",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230360.pdf",
   "indications": "The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230097",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-06",
   "date_received": "2023-01-13",
   "applicant": "Shenzhen Bsx Technology Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230097",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230097.pdf",
   "indications": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K222012",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-05",
   "date_received": "2022-07-08",
   "applicant": "Foreo, Inc.",
   "device_name": "FAQ 101",
   "product_code": "PAY",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222012",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222012.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K230107",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-05",
   "date_received": "2023-01-13",
   "applicant": "Kam Yuen Plastic Products , Ltd.",
   "device_name": "Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230107",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230107.pdf",
   "indications": "Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230336",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-04-05",
   "date_received": "2023-02-07",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230336",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230336.pdf",
   "indications": "The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230021",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-03-31",
   "date_received": "2023-01-04",
   "applicant": "Shenzhen Yangyi Technology ., Ltd.",
   "device_name": "IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230021",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230021.pdf",
   "indications": "IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K223928",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-03-28",
   "date_received": "2022-12-30",
   "applicant": "Shenzhen Fansizhe Science and Technology Co., Ltd.",
   "device_name": "Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223928",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223928.pdf",
   "indications": "The Intense Pulsed Light (IPL) System (Model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K) is an over-the-counter device intended for the removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K230124",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-03-15",
   "date_received": "2023-01-17",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230124",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230124.pdf",
   "indications": "The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K230060",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-03-03",
   "date_received": "2023-01-09",
   "applicant": "Shenzhen Gsd Tech Co., Ltd.",
   "device_name": "Light Based Hair Removal Device GP592",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230060",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230060.pdf",
   "indications": "Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K223618",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-02-28",
   "date_received": "2022-12-05",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223618",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223618.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K223544",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-02-23",
   "date_received": "2022-11-25",
   "applicant": "Guangdong Newdermo Biotech Co., Ltd.",
   "device_name": "LED light therapy mask (FM-01, FM-02, FM-03)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223544",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223544.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K223524",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-02-16",
   "date_received": "2022-11-23",
   "applicant": "Morlaser Shenzhen Co., Ltd.",
   "device_name": "IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223524",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223524.pdf",
   "indications": "The IPL Hair Removal is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K222685",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2023-02-08",
   "date_received": "2022-09-06",
   "applicant": "Dermal Photonics Corp",
   "device_name": "NIRA Model 2",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222685",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222685.pdf",
   "indications": "The NIRA Model 2 is indicated for the treatment of periorbital wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K223482",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-12-21",
   "date_received": "2022-11-18",
   "applicant": "Led Technologies, Inc.",
   "device_name": "reVive Light Therapy® Wrinkle and Acne LED Device",
   "product_code": "OHS",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223482",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223482.pdf",
   "indications": "The reVive Light Therapy® Wrinkle and Acne LED Device is intended for treatment of wrinkles and mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K221011",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-12-20",
   "date_received": "2022-04-05",
   "applicant": "Venus Concept USA, Inc.",
   "device_name": "AI.ME System",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221011",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221011.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K221070",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-12-20",
   "date_received": "2022-04-12",
   "applicant": "Equipmed USA, LLC",
   "device_name": "DP4 Microneedling device",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221070",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221070.pdf",
   "indications": "The DP4 microneedling device is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III, IV and V in adults aged 22 years or older.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K221775",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-12-20",
   "date_received": "2022-06-21",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221775",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221775.pdf",
   "indications": "For MK-78, MK-04, The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles. For MK66-H, EL00003 The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K221444",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-12-08",
   "date_received": "2022-05-18",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "LED Eye Perfector, model: EY-36A, EY-36B",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221444",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221444.pdf",
   "indications": "The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K222710",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-12-01",
   "date_received": "2022-09-08",
   "applicant": "Shenzhen Siken 3D Technology Development Co., Ltd.",
   "device_name": "IPL Cooling Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222710",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222710.pdf",
   "indications": "IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K221946",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-11-22",
   "date_received": "2022-07-05",
   "applicant": "Light Tree Ventures Europe B.V.",
   "device_name": "LED Light Therapy Mask (model: MK66R-B)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "NL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221946",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221946.pdf",
   "indications": "The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K222477",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-11-18",
   "date_received": "2022-08-16",
   "applicant": "Dongguan Lescolton Medical Equipment Co., Ltd.",
   "device_name": "Hair Growth Device",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222477",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222477.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K222598",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-11-17",
   "date_received": "2022-08-29",
   "applicant": "Shenzhen Noble Smart Manufacturing Tech Co., Ltd.",
   "device_name": "IPL Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222598",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222598.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K223278",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-11-17",
   "date_received": "2022-10-24",
   "applicant": "Y & J Bio Co., Ltd.",
   "device_name": "easy Claire",
   "product_code": "OHS",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223278",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223278.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The easy Claire is an over-the-counter medical device intended for the use in the treatment of full face wrinkles."
  },
  {
   "id": "K222364",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-11-16",
   "date_received": "2022-08-04",
   "applicant": "Xtrallux, LLC",
   "device_name": "Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222364",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222364.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 3,
   "indications_withheld": "The Xtrallux Alpha, Super Plus, Turbo Pro, and Extreme RX are intended to treat Androgenetic Alopecia (AGA) and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and, females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV."
  },
  {
   "id": "K222377",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-11-03",
   "date_received": "2022-08-05",
   "applicant": "Cellreturn Co., Ltd.",
   "device_name": "Led Mask Platinum Md",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222377",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222377.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K221443",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-10-21",
   "date_received": "2022-05-18",
   "applicant": "Xtreem Pulse, LLC",
   "device_name": "PureLift Pro Plus",
   "product_code": "NFO",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221443",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221443.pdf",
   "indications": "Intended for facial stimulation and indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K221643",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-10-21",
   "date_received": "2022-06-06",
   "applicant": "Shenzhen Desida Technology Co., Ltd.",
   "device_name": "Hair Removal Device (Model: IPL-D26, IPL-D19)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221643",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221643.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K222199",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-10-21",
   "date_received": "2022-07-22",
   "applicant": "Induction Therapies, LLC",
   "device_name": "Collagen P.I.N. (Percutaneous Induction Needling)",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222199",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222199.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Collagen P.I.N. (Percutaneous Induction Needling) microneedling system is indicated for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older."
  },
  {
   "id": "K222537",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-10-14",
   "date_received": "2022-08-22",
   "applicant": "Shenzhen Ishine Technology Company Limited",
   "device_name": "IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222537",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222537.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K222081",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-10-13",
   "date_received": "2022-07-15",
   "applicant": "Freedom Laser Therapy, Inc.",
   "device_name": "ID-510 iRestore Elite",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222081",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222081.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 3,
   "indications_withheld": "The ID-510 iRestore Elite is indicated to promote hair growth in males who have NorwoodHamilton Classifications of IIa-V, and in females with androgenetic alopecia who have LudwigSavin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_odd": [
    "ludwigsavin"
   ]
  },
  {
   "id": "K222432",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-10-11",
   "date_received": "2022-08-12",
   "applicant": "Hunan Guangye Biotechnology Co., Ltd.",
   "device_name": "IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222432",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222432.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
  },
  {
   "id": "K222316",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-09-28",
   "date_received": "2022-08-02",
   "applicant": "Shenzhen Goodwind Technology Development Co., Ltd.",
   "device_name": "IPL Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222316",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222316.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair."
  },
  {
   "id": "K221553",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-09-15",
   "date_received": "2022-05-31",
   "applicant": "Ulike Co., Ltd.",
   "device_name": "Diamond Air+ (UI04A, UI04B, UI04C)",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221553",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221553.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.."
  },
  {
   "id": "K221635",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-08-31",
   "date_received": "2022-06-06",
   "applicant": "Shenzhen Desida Technology Co., Ltd.",
   "device_name": "IPL sapphire ice cooling hair remove device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221635",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221635.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair."
  },
  {
   "id": "K221466",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-08-12",
   "date_received": "2022-05-19",
   "applicant": "Shenzhen Century Dongyuan Technology CO , Ltd.",
   "device_name": "IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221466",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221466.pdf",
   "indications": "The IPL Hair Removal Device (Model: AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K221451",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-08-01",
   "date_received": "2022-05-18",
   "applicant": "Shenzhen Lizbella Technology Co.,Ltd",
   "device_name": "IPL hair removal",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221451",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221451.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "IPL hair removal is an over-the-counter device intended for removal of unwanted body hair."
  },
  {
   "id": "K221430",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-07-27",
   "date_received": "2022-05-17",
   "applicant": "Led Technologies, Inc.",
   "device_name": "reVive Light Therapy LED Cleansing System",
   "product_code": "OHS",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221430",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221430.pdf",
   "indications": "The reVive Light Therapy® LED Cleansing System is intended for treatment of wrinkles and mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K220064",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-07-22",
   "date_received": "2022-01-10",
   "applicant": "Yrs Group, Inc.",
   "device_name": "Synergy Marble (Model: Opasm)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220064",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220064.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "SYNERGY MARBLE is a hand-held device for over-the counter aesthetic purposes. The device red light and amber light are intended for the use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne."
  },
  {
   "id": "K221151",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-07-19",
   "date_received": "2022-04-20",
   "applicant": "Hunan Guangye Biotechnology Co., Ltd.",
   "device_name": "Beauty LED Mask, Model: KFB265",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221151",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221151.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K213056",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-07-07",
   "date_received": "2021-09-22",
   "applicant": "Shenzhen Osto Technology Company Limited",
   "device_name": "LED Facial Mask",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213056",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213056.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "LED Facial Mask is an over the counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The Red and Infrared light combination mode is intended for the treatment of full-face wrinkles. The blue light is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only."
  },
  {
   "id": "K221246",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-07-07",
   "date_received": "2022-05-02",
   "applicant": "Shenzhen Semlamp Intelligent Technology Co., Ltd.",
   "device_name": "IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221246",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221246.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair."
  },
  {
   "id": "K221679",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-07-07",
   "date_received": "2022-06-09",
   "applicant": "Shenzhen Mywin Technology Co., Ltd.",
   "device_name": "IPL Hair Remover, Model: G993, G996, G998 and G885",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221679",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221679.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "IPL Hair Remover is an over-the-counter device intended for removal of unwanted body and/or facial hair."
  },
  {
   "id": "K220248",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-07-01",
   "date_received": "2022-01-31",
   "applicant": "Shenzhen Mareal Tech Co., Ltd.",
   "device_name": "Home use hair removal device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220248",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220248.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V."
  },
  {
   "id": "K221569",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-06-30",
   "date_received": "2022-05-31",
   "applicant": "Shenzhen Fansizhe Science and Technology Co., Ltd.",
   "device_name": "Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221569",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221569.pdf",
   "indications": "The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K213789",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-06-24",
   "date_received": "2021-12-06",
   "applicant": "Yibin Yingtong Intelligent Technology Co., Ltd.",
   "device_name": "Intelligence LaserComb",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213789",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213789.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 5,
   "indications_withheld": "The Intelligence Laser Comb (Model: YTLC001-W) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.",
   "indications_odd": [
    "ytlc"
   ]
  },
  {
   "id": "K220729",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-06-09",
   "date_received": "2022-03-14",
   "applicant": "Luminance Medical Ventures, Inc.",
   "device_name": "The Luminance RED Acne Device",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220729",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220729.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K220927",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-06-02",
   "date_received": "2022-03-31",
   "applicant": "Shenzhen Qiaochengli Technology Co., Ltd.",
   "device_name": "IPL Hair Removal",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220927",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220927.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K221002",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-06-01",
   "date_received": "2022-04-04",
   "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221002",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221002.pdf",
   "indications": "IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K213027",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-05-26",
   "date_received": "2021-09-21",
   "applicant": "Kam Yuen Plastic Products , Ltd.",
   "device_name": "Laser Hair Growth Comb",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213027",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213027.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Laser Hair Growth Comb (Model: A-803) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications ofHa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of1-4, II-1, 11-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV."
  },
  {
   "id": "K213039",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-05-25",
   "date_received": "2021-09-22",
   "applicant": "Li-Tek Electronics Technology C0., Ltd.",
   "device_name": "Micro-current facial cold and hot service (model: TPML-100)",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213039",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213039.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for over the counter aesthetic use."
  },
  {
   "id": "K210545",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-05-20",
   "date_received": "2021-02-25",
   "applicant": "Marci Beauty, Inc.",
   "device_name": "Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210545",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210545.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only."
  },
  {
   "id": "K220168",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-05-17",
   "date_received": "2022-01-20",
   "applicant": "Shenzhen Kaiyan Medical CO , Ltd.",
   "device_name": "Skin Care Beauty Mask (Model: MJ-06)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220168",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220168.pdf",
   "indications": "The Skin Care Beauty Mask (Model: MJ-06) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K220669",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-05-16",
   "date_received": "2022-03-07",
   "applicant": "Shenzhen Junbobeauty Technology Co., Ltd.",
   "device_name": "IPL HAIR REMOVAL HANDSET, Model: IPL-666",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220669",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220669.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K213025",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-05-12",
   "date_received": "2021-09-21",
   "applicant": "Kam Yuen Plastic Products , Ltd.",
   "device_name": "Laser hair growth helmet",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213025",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213025.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications lIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV."
  },
  {
   "id": "K221001",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-05-12",
   "date_received": "2022-04-04",
   "applicant": "Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.",
   "device_name": "IPL Home Use Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221001",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221001.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair."
  },
  {
   "id": "K220645",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-04-27",
   "date_received": "2022-03-04",
   "applicant": "Shenzhen Qianyu Technology Co., Ltd.",
   "device_name": "Hand-held IPL device (JOVS Hair Removal Device)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220645",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220645.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "Hand-held IPL device (JOVS Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair."
  },
  {
   "id": "K220222",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-04-26",
   "date_received": "2022-01-26",
   "applicant": "Shenzhen Yuwei Electronic Technology Co., Ltd.",
   "device_name": "IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220222",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220222.pdf",
   "indications": "IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K220543",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-04-20",
   "date_received": "2022-02-25",
   "applicant": "Auxo Hair, LLC",
   "device_name": "Auxo A300, A150 and APod",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220543",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220543.pdf",
   "indications": null,
   "indications_status": "no document"
  },
  {
   "id": "K212881",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-04-11",
   "date_received": "2021-09-10",
   "applicant": "Shenzhen Fansizhe Science and Technology Co., Ltd.",
   "device_name": "Intense Pulsed Light (IPL) System",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212881",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212881.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K212947",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-04-02",
   "date_received": "2021-09-15",
   "applicant": "Carol Cole Company Dba Nuface",
   "device_name": "Trinity Plus Wrinkle Reducer",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212947",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212947.pdf",
   "indications": "The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held device intended for the reduction of full-face fine lines and wrinkles, and increase in local circulation within the perioral region.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K214113",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-03-28",
   "date_received": "2021-12-30",
   "applicant": "Shenzhen Qianyu Technology Co., Ltd.",
   "device_name": "Hand-held IPL device(JOVS Graphene Hair Removal Device)",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214113",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K214113.pdf",
   "indications": "The Hand-held IPL device (JOVS Graphene Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K214101",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-03-23",
   "date_received": "2021-12-29",
   "applicant": "Duplex International Trading Limited",
   "device_name": "Project E Beauty LED Light Therapy Mask (Model: PE730)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214101",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K214101.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Project E Beauty LED Light Therapy Mask is an over the counter device that is indicated for the treatment of full face wrinkles and mild to moderate acne."
  },
  {
   "id": "K214103",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-03-22",
   "date_received": "2021-12-29",
   "applicant": "Harpar Grace International",
   "device_name": "Shani Darden LED light therapy mask",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214103",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K214103.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles."
  },
  {
   "id": "K210823",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-03-18",
   "date_received": "2021-03-19",
   "applicant": "Lyma Life , Ltd.",
   "device_name": "LYMA Laser",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210823",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210823.pdf",
   "indications": "The LYMA Laser is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K220506",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-03-07",
   "date_received": "2022-02-22",
   "applicant": "Crown Aesthetics",
   "device_name": "SkinPen Precision System",
   "product_code": "QAI",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220506",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220506.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The SkinPen@ Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older."
  },
  {
   "id": "K213285",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-03-03",
   "date_received": "2021-10-01",
   "applicant": "Y & J Bio Co., Ltd.",
   "device_name": "easy Claire",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213285",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213285.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The easy Claire is an over-the-counter medical device intended for the use in the treatment of full face wrinkles."
  },
  {
   "id": "K214100",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-02-24",
   "date_received": "2021-12-29",
   "applicant": "Premier North America, Inc.",
   "device_name": "Luminice",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214100",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K214100.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K213830",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-02-01",
   "date_received": "2021-12-08",
   "applicant": "Iluminage Beauty Co., Limited",
   "device_name": "Home use hair removal device, model: Precise Touch Pro",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "HK",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213830",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213830.pdf",
   "indications": "The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K212771",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-01-26",
   "date_received": "2021-08-31",
   "applicant": "Led Intellectual Properties, LLC",
   "device_name": "LightStim Elipsa",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212771",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212771.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 5,
   "indications_withheld": "The LightStim Elipsa is a LED light therapy device which uses specific wavelengths of light, produced by light emitting diodes (LEDs. It is intended to emit energy in the red and infrared region of the light spectrum to provide treatment for full face wrinkles. The blue and red light spectrum is intended for the treatment of mild to moderate inflammatory acne."
  },
  {
   "id": "K213692",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-01-26",
   "date_received": "2021-11-23",
   "applicant": "Cyden Limited",
   "device_name": "SmoothSkin Pure Mini",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213692",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213692.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K213447",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-01-19",
   "date_received": "2021-10-25",
   "applicant": "Shenzhen Cosbeauty Technology Co., Ltd.",
   "device_name": "LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213447",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213447.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K212318",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-01-14",
   "date_received": "2021-07-26",
   "applicant": "Dongguan Define Beauty Electronic Technology Co., Ltd.",
   "device_name": "IPL Hair Removal",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212318",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212318.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K213841",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2022-01-06",
   "date_received": "2021-12-09",
   "applicant": "Premier North America, Inc.",
   "device_name": "ENEO TOTALE (Model: ENEOT947)",
   "product_code": "OHS",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213841",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213841.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "ENEO TOTALE is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles."
  },
  {
   "id": "K213024",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-12-22",
   "date_received": "2021-09-21",
   "applicant": "Shenzhen Kaiyan Medical CO , Ltd.",
   "device_name": "Oren LED Perioral Light Therapy System",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213024",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213024.pdf",
   "indications": "The Oren LED Perioral Light Therapy System (Model: OR-01) is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K213094",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-12-22",
   "date_received": "2021-09-24",
   "applicant": "Freedom Laser Therapy, Inc.",
   "device_name": "ID-500 iRestore Hair Growth System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213094",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213094.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K210968",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-12-21",
   "date_received": "2021-03-31",
   "applicant": "Led Technologies, Inc.",
   "device_name": "reVive Light Therapy Essentials",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210968",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210968.pdf",
   "indications": "The reVive Light Therapy® Essentials is an Over the Counter (OTC) LED device intended for use in treating mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K212155",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-12-21",
   "date_received": "2021-07-12",
   "applicant": "Theragun, Inc.",
   "device_name": "TheraFace LED",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212155",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212155.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K211185",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-12-20",
   "date_received": "2021-04-20",
   "applicant": "Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.",
   "device_name": "IPL Home Use Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211185",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211185.pdf",
   "indications": "IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K213020",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-12-16",
   "date_received": "2021-09-20",
   "applicant": "Shenzhen Borria Technology Co., Ltd.",
   "device_name": "IPL hair removal machine",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213020",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213020.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs."
  },
  {
   "id": "K210965",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-12-15",
   "date_received": "2021-03-31",
   "applicant": "Led Technologies, Inc.",
   "device_name": "reVive Light Therapy Essentials",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210965",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210965.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K212558",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-11-24",
   "date_received": "2021-08-13",
   "applicant": "Eclipse Medcorp, LLC",
   "device_name": "MicroPen EVO",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212558",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212558.pdf",
   "indications": "The Eclipse MicroPen® EVO is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K213184",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-11-23",
   "date_received": "2021-09-29",
   "applicant": "Mz Skin",
   "device_name": "MZ Skin LightMAX Supercharged LED Mask 2.0",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213184",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213184.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K212697",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-11-19",
   "date_received": "2021-08-25",
   "applicant": "Shenzhen Leaflife Technology Co., Ltd.",
   "device_name": "Leaf Smooth",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212697",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212697.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K212275",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-11-18",
   "date_received": "2021-07-20",
   "applicant": "Aesthetic Technology, Ltd.",
   "device_name": "Dermalux Flex MD",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212275",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212275.pdf",
   "indications": "Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. Intended to emit energy in the red and infrared spectrum for use in dermatology for the treatment of periorbital and full face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K213041",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-11-18",
   "date_received": "2021-09-22",
   "applicant": "Glan Electronics Co., Ltd.",
   "device_name": "IPL Hair Removal, Model: OBT-02",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213041",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213041.pdf",
   "indications": "The IPL Hair Removal Device OBT-02 Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K211055",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-11-05",
   "date_received": "2021-04-09",
   "applicant": "Shenzhen DJ Medical Equipment Co., Ltd.",
   "device_name": "Microcurrent device (Model: HBR2-1)",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211055",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211055.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K212897",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-11-04",
   "date_received": "2021-09-10",
   "applicant": "Shenzhen Century Dongyuan Technology CO , Ltd.",
   "device_name": "IPL Hair Removal Device, model: AI01",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212897",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212897.pdf",
   "indications": "The IPL Hair Removal Device (Model: AI01) is intended for the removal of unwanted body hair.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K212314",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-10-21",
   "date_received": "2021-07-23",
   "applicant": "Zhongshan Bisen Plastic Electronic Products Co., Ltd.",
   "device_name": "IPL Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212314",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212314.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K210376",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-10-07",
   "date_received": "2021-02-09",
   "applicant": "Guangzhou Haoxingwan Technology Co., Ltd.",
   "device_name": "Superior Hair Remover",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210376",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210376.pdf",
   "indications": "The Superior Hair Remover is an over the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K212238",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-09-29",
   "date_received": "2021-07-19",
   "applicant": "Theragun, Inc.",
   "device_name": "TheraFace Microcurrent",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212238",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212238.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K212342",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-09-23",
   "date_received": "2021-07-28",
   "applicant": "Ziip, Inc.",
   "device_name": "ZIIP+ Device",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212342",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212342.pdf",
   "indications": "The ZIIP+ Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K211922",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-09-20",
   "date_received": "2021-06-21",
   "applicant": "Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.",
   "device_name": "IPL Home Use Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211922",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211922.pdf",
   "indications": "IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K211174",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-09-01",
   "date_received": "2021-04-20",
   "applicant": "Shenzhen Qiaochengli Technology Co., Ltd.",
   "device_name": "IPL Hair Removal",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211174",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211174.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 5,
   "indications_withheld": "The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician，after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.",
   "indications_odd": [
    "tfda"
   ]
  },
  {
   "id": "K211994",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-07-28",
   "date_received": "2021-06-28",
   "applicant": "Cyden Limited",
   "device_name": "Braun Silk.expert Mini",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211994",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211994.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K210311",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-07-23",
   "date_received": "2021-02-03",
   "applicant": "Shenzhen Mismon Technology Co., Ltd.",
   "device_name": "Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210311",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210311.pdf",
   "indications": "The Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K203214",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-07-22",
   "date_received": "2020-11-02",
   "applicant": "Shenzhen Kaiyan Medical CO , Ltd.",
   "device_name": "DemarkQ WOW, DemarkQ POP",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203214",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203214.pdf",
   "indications": "The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K203271",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-07-21",
   "date_received": "2020-11-06",
   "applicant": "Shenzhen Kaiyan Medical CO , Ltd.",
   "device_name": "Aduro light therapy Handheld",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203271",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203271.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K211192",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-07-20",
   "date_received": "2021-04-21",
   "applicant": "Leana Orders, Inc.",
   "device_name": "Grivamax Family of Lasers, Models 272 and 148",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211192",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211192.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The Grivamax Family of Lasers , Models 272 and 148 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K200983",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-07-14",
   "date_received": "2020-04-14",
   "applicant": "Ningbo Hesi Electric Co., Ltd.",
   "device_name": "Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200983",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200983.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles. The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles - The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation."
  },
  {
   "id": "K202390",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-07-14",
   "date_received": "2020-08-21",
   "applicant": "Shenzhen Kaiyan Medical CO , Ltd.",
   "device_name": "Aduro Light Beauty Mask",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202390",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202390.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "For MK-660, MK-66USBO, MK-020: The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne. For MK-66USBA, MK-02A: The Aduro Light Beauty Mask (Model: MK-66USBA, MK-02A) is intended to emit light in the blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face. For MK-66USBB, MK-02B: The Aduro Light Beauty Mask (Model: MK-66USBB, MK-02B) is an over the counter device that is intended for the use in the treatment of full-face wrinkles."
  },
  {
   "id": "K202517",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-07-09",
   "date_received": "2020-09-01",
   "applicant": "Cytrellis Biosystems, Inc.",
   "device_name": "Cytrellis Dermal Micro-Coring System",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202517",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202517.pdf",
   "indications": "The Cytrellis Dermal Micro-Coring System is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K210954",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-06-29",
   "date_received": "2021-03-30",
   "applicant": "Yrs Group, Inc.",
   "device_name": "Synergy",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210954",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210954.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K211038",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-06-29",
   "date_received": "2021-04-07",
   "applicant": "Biophotas, Inc.",
   "device_name": "Biophotas Celluma RESTORE",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211038",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211038.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 5,
   "indications_withheld": "The BioPhotas Celluma RESTORE is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in 2 females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV."
  },
  {
   "id": "K210948",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-06-24",
   "date_received": "2021-03-30",
   "applicant": "Globalmed Technologies",
   "device_name": "Omnilux CLEAR",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210948",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210948.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K203144",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-05-25",
   "date_received": "2020-10-21",
   "applicant": "Eclipse Medcorp, LLC",
   "device_name": "MicroPen EVO",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203144",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203144.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Eclipse MicroPen EVO is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older."
  },
  {
   "id": "K191951",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-04-27",
   "date_received": "2019-07-22",
   "applicant": "Avazzia, Inc.",
   "device_name": "Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191951",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191951.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K202055",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-04-16",
   "date_received": "2020-07-24",
   "applicant": "Heat IN A Click, LLC",
   "device_name": "Looper (Model: ZX-579S)",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202055",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202055.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the face, and the blue light is indicated for the treatment of the mild to moderate inflammatory acne."
  },
  {
   "id": "K210169",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-04-16",
   "date_received": "2021-01-22",
   "applicant": "Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd.",
   "device_name": "Hair Growth Device",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210169",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210169.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Hair Growth Device is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton Norwood Classifications ofIla-V and females with androgenetic alopecia who have Ludwig-Savin Classifications ofl-II and Fitzpatrick Classification ofSkin Phototypes I to IV."
  },
  {
   "id": "K202243",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-04-02",
   "date_received": "2020-08-10",
   "applicant": "Crown Aesthetics",
   "device_name": "SkinPen Precision System",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202243",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202243.pdf",
   "indications": "The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K203826",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-03-29",
   "date_received": "2020-12-29",
   "applicant": "Transdermal Cap, Inc.",
   "device_name": "LaserCap Family of Lasers 300, 224, 120 & 80",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203826",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203826.pdf",
   "indications": "The LaserCap Family of Lasers, models 300, 224, 120 and 80 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, and males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K203510",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-02-26",
   "date_received": "2020-11-30",
   "applicant": "Shenzhen Weikai Technology Co.,Ltd",
   "device_name": "IPL Hair removal",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203510",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203510.pdf",
   "indications": "IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K203665",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-02-25",
   "date_received": "2020-12-16",
   "applicant": "Pollogen, Ltd.",
   "device_name": "STOP U Model UXV Device",
   "product_code": "PAY",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203665",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203665.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K201906",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-02-24",
   "date_received": "2020-07-09",
   "applicant": "Carol Cole Company Dba Nuface",
   "device_name": "Trinity ELE Plus and Trinity ELE Plus Pro",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201906",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201906.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K201680",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-02-19",
   "date_received": "2020-06-22",
   "applicant": "Carole Cole Company",
   "device_name": "NuFACE Mini Plus",
   "product_code": "NFO",
   "clearance_type": "Abbreviated",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201680",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201680.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K201782",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2021-01-22",
   "date_received": "2020-06-30",
   "applicant": "Carol Cole Company Dba Nuface",
   "device_name": "NuFace Trinity Plus Device",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201782",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201782.pdf",
   "indications": "The NūFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K202631",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-12-08",
   "date_received": "2020-09-11",
   "applicant": "Slinph Technologies Co., Ltd.",
   "device_name": "iHelmet Laser Comb",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202631",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202631.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K202983",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-12-08",
   "date_received": "2020-09-30",
   "applicant": "Y & J Bio Co., Ltd.",
   "device_name": "easy Hairfull",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202983",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202983.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The easy Hairfull is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ha to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of 1-Il and Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K193008",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-12-03",
   "date_received": "2019-10-28",
   "applicant": "Advihair S.R.L.",
   "device_name": "Tricoglam Home Use",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IT",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193008",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193008.pdf",
   "indications": "Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K202442",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-11-19",
   "date_received": "2020-08-26",
   "applicant": "Carewear Corp.",
   "device_name": "Carewear Firefly Wrinkle Reduction",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202442",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202442.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K192077",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-09-30",
   "date_received": "2019-08-02",
   "applicant": "Vupiesse S.R.L",
   "device_name": "Tua Face Fitness / Tua Trend Face",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IT",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192077",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192077.pdf",
   "indications": "Tua Face Fitness / Tua Trend Face is a device intended for facial stimulation and is indicated for Over-the-Counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K201854",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-09-01",
   "date_received": "2020-07-06",
   "applicant": "Nature, Inc.redible, Inc.",
   "device_name": "CAPOGEN Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201854",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201854.pdf",
   "indications": "CAPOGEN Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have NorwoodHamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K200803",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-07-31",
   "date_received": "2020-03-27",
   "applicant": "Foreo, Inc.",
   "device_name": "BEAR and BEAR mini",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200803",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200803.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The BEAR and BEAR mini devices are intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use."
  },
  {
   "id": "K200464",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-07-23",
   "date_received": "2020-02-26",
   "applicant": "Lg Electronics.Inc",
   "device_name": "LG Pra. L Derma LD Scalp Care",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200464",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200464.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The LG Pra.L Derma LD Scalp Care is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications ofl-11 and Fitzpatrick Classification ofSkin Phototypes I to IV."
  },
  {
   "id": "K201107",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-06-22",
   "date_received": "2020-04-24",
   "applicant": "Gtg Wellness Co., Ltd.",
   "device_name": "Opera Lebody (Gold), Opera Lebody (Zafiro)",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201107",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201107.pdf",
   "indications": "OPERA LEBODY is an over the counter device that is intended for the use in the treatment of full face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K200929",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-06-03",
   "date_received": "2020-04-07",
   "applicant": "Xuzhou Kernel Medical Equipment Co., Ltd.",
   "device_name": "Hair Growth System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200929",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200929.pdf",
   "indications": "The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000D/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K192295",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-05-01",
   "date_received": "2019-08-23",
   "applicant": "Beijing Adss Development Co., Ltd.",
   "device_name": "PDT-FACE",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192295",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192295.pdf",
   "indications": "The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. The device is indicated for adults only.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K192552",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-04-17",
   "date_received": "2019-09-17",
   "applicant": "Chongqing Peninsula Medical Technology Co., Ltd.",
   "device_name": "Irradiation Cosmetic Device",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192552",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192552.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K200044",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-04-10",
   "date_received": "2020-01-08",
   "applicant": "Esthetic Education, LLC",
   "device_name": "SkinStylus SteriLock MicroSystem",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200044",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200044.pdf",
   "indications": "The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K192138",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-04-09",
   "date_received": "2019-08-08",
   "applicant": "Refine USA, LLC",
   "device_name": "Rejuvapen NXT",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192138",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192138.pdf",
   "indications": "The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use on adults at least 22 years of age.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K193667",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-03-25",
   "date_received": "2019-12-31",
   "applicant": "Conversion Labs, Pr, LLC",
   "device_name": "Shapiro MD model laser 272",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193667",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193667.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 3,
   "indications_withheld": "The Shapiro MD, Model Laser 272 is indicated to promote hair growth in males with androgenic alopecia who have Norwood•Hamilton Classifications of Ila• V, or females with androgenic alopecia who have Ludwig•Savin Classifications I· II, and for both, with Fitzpatrick Skin Phototypes I· IV."
  },
  {
   "id": "K200184",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-02-21",
   "date_received": "2020-01-24",
   "applicant": "Cyden Limited",
   "device_name": "SmoothSkin Pure",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200184",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200184.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 3,
   "indications_withheld": "The SmoothSkin Pure Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin Pure is also indicated for the permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_odd": [
    "longterm"
   ]
  },
  {
   "id": "K192585",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2020-01-29",
   "date_received": "2019-09-19",
   "applicant": "Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC",
   "device_name": "Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192585",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192585.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 3,
   "indications_withheld": "The Bosley Revitalizer 96 Laser Cap is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV."
  },
  {
   "id": "K190467",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-12-26",
   "date_received": "2019-02-26",
   "applicant": "Slinph Technologies Co., Ltd.",
   "device_name": "iHelmet Hair Growth System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190467",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190467.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K192627",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-12-13",
   "date_received": "2019-09-23",
   "applicant": "Shang FA Biotechnology Co.",
   "device_name": "Laser Hair Growth Cap",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "TW",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192627",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192627.pdf",
   "indications": "Laser Hair Growth Cap is indicated to promote hair growth in males with androgenic alopecia who have NorwoodHamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K191754",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-11-22",
   "date_received": "2019-07-01",
   "applicant": "Kunshan Bella Optical Technology Co., Ltd.",
   "device_name": "Hair Growth System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191754",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191754.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 3,
   "indications_withheld": "Hair Growth System, Models: SPARK-3 and SPARK-4 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwing -Savin Classifications of I -Ⅱ, in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ⅱa - V and for both, Fitzpatrick Classification of Skin Phototypes I to Ⅳ.",
   "indications_odd": [
    "ludwing"
   ]
  },
  {
   "id": "K192432",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-11-08",
   "date_received": "2019-09-05",
   "applicant": "Shenzhen Bosidin Technology Co., Ltd.",
   "device_name": "IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192432",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192432.pdf",
   "indications": "IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K191672",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-10-15",
   "date_received": "2019-06-24",
   "applicant": "Carol Cole Company Dba Nuface",
   "device_name": "NuFACE Mini Device",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191672",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191672.pdf",
   "indications": "The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K190820",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-10-02",
   "date_received": "2019-04-01",
   "applicant": "Kam Yuen Plastic Products , Ltd.",
   "device_name": "Aimanfun Lumea Comfort",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190820",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190820.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K192425",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-09-30",
   "date_received": "2019-09-05",
   "applicant": "Wontech Co., Ltd.",
   "device_name": "Hair Boom 69, Hair Boom Air, Ulike Hair UpUp",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192425",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192425.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 4,
   "indications_withheld": "The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications ofl - II, males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K192010",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-09-24",
   "date_received": "2019-07-29",
   "applicant": "Cyden Limited",
   "device_name": "SmoothSkin BARE+",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192010",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192010.pdf",
   "indications": "The SmoothSkin BARE+ Hair Removal Device is indicated for the removal of unwanted hair. The SmoothSkin BARE+ is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K183708",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-09-17",
   "date_received": "2018-12-31",
   "applicant": "Medtek Skincare, LLC",
   "device_name": "Poly Clear",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183708",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183708.pdf",
   "indications": "The Poly Clear combination of Red (633nm±10nm) and Blue (417nm±10nm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K191629",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-09-12",
   "date_received": "2019-06-19",
   "applicant": "Ismart Marketing Svcs, Ltd.",
   "device_name": "faceLITE",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191629",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191629.pdf",
   "indications": "The faceLITE LED mask is an over the counter device that is intended for the use in the treatment of full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K192012",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-09-12",
   "date_received": "2019-07-29",
   "applicant": "Capillus",
   "device_name": "Capillus 112, Capillus 244",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192012",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192012.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K190269",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-08-28",
   "date_received": "2019-02-08",
   "applicant": "Xtreem Pulse, LLC",
   "device_name": "PureLift",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190269",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190269.pdf",
   "indications": "PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K191154",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-07-29",
   "date_received": "2019-05-01",
   "applicant": "Wontech",
   "device_name": "Hair Boom 69",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191154",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191154.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K190685",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-07-26",
   "date_received": "2019-03-18",
   "applicant": "Xuzhou Kernel Medical Equipment Co., Ltd.",
   "device_name": "Hair Growth System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190685",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190685.pdf",
   "indications": "The Hair Growth System (Model: KN-8000A) is a prescription use device intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K182407",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-07-19",
   "date_received": "2018-09-04",
   "applicant": "Mt. Derm GmbH",
   "device_name": "Exceed Microneedling device",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "DE",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182407",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182407.pdf",
   "indications": "The Exceed is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K190443",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-06-24",
   "date_received": "2019-02-25",
   "applicant": "Galactic Beauty, LLC",
   "device_name": "MMSphere",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190443",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190443.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K182774",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-06-19",
   "date_received": "2018-10-01",
   "applicant": "Pollogen, Ltd.",
   "device_name": "STOP U (Packed Black USA), STOP U (Packed White USA)",
   "product_code": "PAY",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182774",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182774.pdf",
   "indications": "The STOP U device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K183417",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-05-17",
   "date_received": "2018-12-10",
   "applicant": "Freedom Laser Therapy, Inc.",
   "device_name": "iRestore Professional 282",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183417",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183417.pdf",
   "indications": "The iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, males who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K183189",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-04-17",
   "date_received": "2018-11-19",
   "applicant": "Micro Current Technology, Inc.",
   "device_name": "Ultra OTC Facial Toning System",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183189",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183189.pdf",
   "indications": null,
   "indications_status": "no text layer"
  },
  {
   "id": "K183260",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-03-18",
   "date_received": "2018-11-23",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "Sensilight Pro / Pistol IPL",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183260",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183260.pdf",
   "indications": "The Sensilight Pro device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured 6,9,and 12 months after the completion of treatment regimen.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K190354",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-03-18",
   "date_received": "2019-02-15",
   "applicant": "Cyden Limited",
   "device_name": "BRAUN Silk.expert Pro 5",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190354",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190354.pdf",
   "indications": "The BRAUN Silk.expert Pro 5 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 5 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K190366",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-03-18",
   "date_received": "2019-02-15",
   "applicant": "Cyden Limited",
   "device_name": "BRAUN Silk Expert Pro 3",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190366",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190366.pdf",
   "indications": "The BRAUN Silk.expert Pro 3 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 3 is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K183247",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-03-14",
   "date_received": "2018-11-21",
   "applicant": "Led Technologies, Inc.",
   "device_name": "dpl Faceware",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183247",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183247.pdf",
   "indications": "The dpl® Faceware is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K183217",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-02-15",
   "date_received": "2018-11-19",
   "applicant": "Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.",
   "device_name": "IPL Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183217",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183217.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K183118",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-02-07",
   "date_received": "2018-11-09",
   "applicant": "Led Technologies, Inc.",
   "device_name": "dpl SpotLite",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183118",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183118.pdf",
   "indications": "The dpl® SpotLite is an Over-the-Counter (OTC) device intended for use in treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 7
  },
  {
   "id": "K183671",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-01-22",
   "date_received": "2018-12-27",
   "applicant": "Lg Electronics.Inc",
   "device_name": "LG PRA.L DERMA LED MASK",
   "product_code": "OHS",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183671",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183671.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K183329",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2019-01-16",
   "date_received": "2018-11-30",
   "applicant": "Omm Imports, Inc. D/B/A Zero Gravity",
   "device_name": "Laser Hair Therapy",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183329",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183329.pdf",
   "indications": "Laser Hair Therapy is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K182424",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-12-18",
   "date_received": "2018-09-06",
   "applicant": "Carol Cole Company Dba Nuface",
   "device_name": "NuFACE FIX Skin Toning Device",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182424",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182424.pdf",
   "indications": "The NuFACE FIX™ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K182562",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-11-16",
   "date_received": "2018-09-18",
   "applicant": "Wontech",
   "device_name": "Hair Boom 69",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182562",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182562.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 3,
   "indications_withheld": "The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications ofl - II, males who have Norwood-Hamilton Classifications of Ila- V and for both, Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K182501",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-10-26",
   "date_received": "2018-09-12",
   "applicant": "Pulsaderm, LLC",
   "device_name": "Hair Laser Headband",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182501",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182501.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K181008",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-10-11",
   "date_received": "2018-04-17",
   "applicant": "Carol Cole Company Dba Nuface",
   "device_name": "NuFACE Trinity",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181008",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181008.pdf",
   "indications": "The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K181734",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-09-19",
   "date_received": "2018-07-02",
   "applicant": "Home Well Trading, Ltd.",
   "device_name": "Beurer IPL 8500 device/ IPL VelvetSkin Pro",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "VG",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181734",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181734.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K180875",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-09-14",
   "date_received": "2018-04-03",
   "applicant": "Medtek Skincare, LLC",
   "device_name": "POLY REJUV",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180875",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180875.pdf",
   "indications": "The Poly Rejuv Model 633 is intended to emit energy in the red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K181568",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-09-11",
   "date_received": "2018-06-14",
   "applicant": "Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt",
   "device_name": "IPL Salon Hair Reduction System",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181568",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181568.pdf",
   "indications": "The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6. 9. and 12 months after the completion of a treatment regimen.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K173813",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-09-07",
   "date_received": "2017-12-15",
   "applicant": "Shen Zhen Cosbeauty Co., Ltd.",
   "device_name": "IPL Hair Removal Device Joy Version",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173813",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173813.pdf",
   "indications": "The IPL Hair Removal Device Joy Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults with Fitzpatrick skin types I – IV.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K180778",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-09-07",
   "date_received": "2018-03-26",
   "applicant": "Mt. Derm GmbH",
   "device_name": "Exceed Microneedling Device",
   "product_code": "QAI",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "DE",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180778",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180778.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 3,
   "indications_withheld": "The Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skintypes I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.",
   "indications_odd": [
    "skintypes"
   ]
  },
  {
   "id": "K181878",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-09-05",
   "date_received": "2018-07-13",
   "applicant": "Kiierr International, LLC",
   "device_name": "Kiierr 272 Laser, Kiierr 148 Laser",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181878",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181878.pdf",
   "indications": "The Kiierr Family of Devices, the 272 and 148 Laser Devices are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K180888",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-08-30",
   "date_received": "2018-04-04",
   "applicant": "Uplevity, Inc.",
   "device_name": "LYFT",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180888",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180888.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K181308",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-08-15",
   "date_received": "2018-05-17",
   "applicant": "Super Grow Lasers",
   "device_name": "SuperGrow 272, Ultimate 272",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181308",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181308.pdf",
   "indications": "The SuperGrow 272 laser hat and the Ultimate 272 are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood – Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I‐1 to I‐4, II‐1, II‐2, or frontal; both with Fitzpatrick Skin Types I to IV.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K181253",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-08-10",
   "date_received": "2018-05-11",
   "applicant": "Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC",
   "device_name": "Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181253",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181253.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 3,
   "indications_withheld": "The BOSLEY Revitalizer 272 and 164 Laser Caps are indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-3, or frontal; both with Fitzpatrick Skin Types I to IV."
  },
  {
   "id": "K181659",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-07-26",
   "date_received": "2018-06-25",
   "applicant": "Premier North America, Inc.",
   "device_name": "Avologi ENEO",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181659",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181659.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K181062",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-07-18",
   "date_received": "2018-04-23",
   "applicant": "Micro Current Technology, Inc.",
   "device_name": "Ultra Facial Toning System",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181062",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181062.pdf",
   "indications": "The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K180900",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-07-10",
   "date_received": "2018-04-06",
   "applicant": "Uvbiotek, LLC",
   "device_name": "LED Light Therapy Device",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180900",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180900.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K181121",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-06-28",
   "date_received": "2018-04-30",
   "applicant": "Home Well Trading, Ltd.",
   "device_name": "Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "VG",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181121",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181121.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K180885",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-06-20",
   "date_received": "2018-04-04",
   "applicant": "Lexington International, LLC",
   "device_name": "HairMax Laser",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180885",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180885.pdf",
   "indications": "The HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V, females who have Ludwig-Savin Classifications of I – II or Frontal and for both, Fitzpatrick Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K180847",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-06-19",
   "date_received": "2018-04-02",
   "applicant": "Johnson & Johnson Consumer, Inc.",
   "device_name": "Neutrogena Light Therapy Acne Mask+",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180847",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180847.pdf",
   "indications": "The Neutrogena Light Therapy Acne Mask+ is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K180856",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-06-19",
   "date_received": "2018-04-02",
   "applicant": "Johnson & Johnson Consumer, Inc.",
   "device_name": "Neutrogena Light Therapy Aging Mask+",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180856",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180856.pdf",
   "indications": "The Neutrogena Light Therapy Aging Mask+ is an over the counter device that is indicated for the treatment of full face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K172909",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-06-07",
   "date_received": "2017-09-25",
   "applicant": "Omm Imports D/B/A Zero Gravity",
   "device_name": "ELEVARE, PERFECTIO 4",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172909",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172909.pdf",
   "indications": "The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K173093",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-06-05",
   "date_received": "2017-09-29",
   "applicant": "Tama Research Corporation",
   "device_name": "TAMA BEMS device",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173093",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173093.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K180447",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-06-04",
   "date_received": "2018-02-20",
   "applicant": "Led Technologies, Inc.",
   "device_name": "reVive Light Therapy LED Cleansing System",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180447",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180447.pdf",
   "indications": "The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) device intended for use in treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K180617",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-06-01",
   "date_received": "2018-03-08",
   "applicant": "Y & J Bio Co., Ltd.",
   "device_name": "Hair Up",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180617",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180617.pdf",
   "indications": "The Hair Up is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K180460",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-05-18",
   "date_received": "2018-02-20",
   "applicant": "Theradome, Inc.",
   "device_name": "Theradome LH40",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180460",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180460.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 3,
   "indications_withheld": "The Theradome LH40 (Theragrow) is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.",
   "indications_odd": [
    "theragrow"
   ]
  },
  {
   "id": "K180445",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-05-15",
   "date_received": "2018-02-20",
   "applicant": "Led Technologies, Inc.",
   "device_name": "reVive Light Therapy LED Ultrasonic Wrinkle System",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180445",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180445.pdf",
   "indications": "The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating wrinkles.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K180383",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-05-11",
   "date_received": "2018-02-12",
   "applicant": "Shenzhen Gsd Tech Co., Ltd.",
   "device_name": "Light based hair removal device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180383",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180383.pdf",
   "indications": "Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K172555",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-05-01",
   "date_received": "2017-08-24",
   "applicant": "Omm Imports, Inc. D/B/A Zero Gravity",
   "device_name": "SAPPHIRE, ELEVARE SAPPHIRE",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172555",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172555.pdf",
   "indications": "The SAPPHIRE is an over –the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K171821",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-04-26",
   "date_received": "2017-06-19",
   "applicant": "Heat IN A Click",
   "device_name": "2 Face / Face Evolution",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171821",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171821.pdf",
   "indications": "2 Face / Face Evolution is a hand-held device for over-the counter aesthetic purposes. (1) The EMS mode is indicated for facial stimulation; (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K180320",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-04-03",
   "date_received": "2018-02-05",
   "applicant": "Led Technologies, Inc.",
   "device_name": "dpl IIa Panel",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180320",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180320.pdf",
   "indications": "The dpl® IIa Panel is an Over-the-Counter (OTC) device intended for use in treating wrinkles, and treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K173846",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-03-21",
   "date_received": "2017-12-19",
   "applicant": "Dermascalp, LLC",
   "device_name": "DermaScalp Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173846",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173846.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K180016",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-03-20",
   "date_received": "2018-01-02",
   "applicant": "Shenzhen Mismon Technology Co., Ltd.",
   "device_name": "Home Use IPL Beauty Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180016",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180016.pdf",
   "indications": "Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "DEN160029",
   "pathway": "De Novo",
   "decision_code": "DENG",
   "decision_description": "Unknown",
   "decision_date": "2018-03-01",
   "date_received": "2016-07-05",
   "applicant": "Bellus Medical, LLC",
   "device_name": "SkinPen Precision System",
   "product_code": "QAI",
   "clearance_type": "Direct",
   "statement_or_summary": "",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160029",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160029.pdf",
   "indications": "SkinPen® Precision System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.",
   "indications_status": "quoted",
   "indications_page": 1
  },
  {
   "id": "K173678",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-02-28",
   "date_received": "2017-11-30",
   "applicant": "Cosmo Far East Technology Limited",
   "device_name": "Diode Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173678",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173678.pdf",
   "indications": "Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K173729",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-02-28",
   "date_received": "2017-12-06",
   "applicant": "Photonmd, Inc.",
   "device_name": "REVIAN RED",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173729",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173729.pdf",
   "indications": "REVIAN RED is indicated to treat Androgenetic Alopecia and promote hair growth in males who have NorwoodHamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K172883",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-02-12",
   "date_received": "2017-09-21",
   "applicant": "Shenzhen Mareal Tech Co., Ltd.",
   "device_name": "Home Use Hair Removal Device/T1, T2, T3",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172883",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172883.pdf",
   "indications": "The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K171835",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-01-30",
   "date_received": "2017-06-20",
   "applicant": "Chongqing Peninsula Medical Technology Co., Ltd.",
   "device_name": "Irradiation Aesthetic Device",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171835",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171835.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K173843",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-01-26",
   "date_received": "2017-12-18",
   "applicant": "Eglobal, LLC",
   "device_name": "illumiflow 148 Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173843",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173843.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K172791",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-01-18",
   "date_received": "2017-09-15",
   "applicant": "Conair Corporation",
   "device_name": "Lumilisse IPL Hair Remover",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172791",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172791.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K171775",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-01-09",
   "date_received": "2017-06-14",
   "applicant": "Theradome, Inc.",
   "device_name": "Theradome LH80 PRO",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171775",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171775.pdf",
   "indications": "The Theradome LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K172662",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-01-09",
   "date_received": "2017-09-05",
   "applicant": "Led Technologies, Inc.",
   "device_name": "reVive Perioral",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172662",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172662.pdf",
   "indications": "The reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K172968",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2018-01-05",
   "date_received": "2017-09-26",
   "applicant": "Y & J Bio Co., Ltd.",
   "device_name": "Hair Up",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172968",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172968.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K163550",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-12-20",
   "date_received": "2016-12-19",
   "applicant": "Habalan Med & Beauty Co.,Ltd",
   "device_name": "Pobling MIITY 2",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163550",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163550.pdf",
   "indications": "The Pobling MIITY 2 is intended for facial stimulation and is indicated for over-the counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K172982",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-12-19",
   "date_received": "2017-09-27",
   "applicant": "Super Grow Lasers",
   "device_name": "SuperGrow 272, Ultimate 272",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172982",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172982.pdf",
   "indications": "The SuperGrow 272 laser hat and the Ultimate 272 are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood – Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K162652",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-10-25",
   "date_received": "2016-09-23",
   "applicant": "Li-Tek Electronic Technology Corporation",
   "device_name": "Smart Photon Micro-current Device, Model: EP-300",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162652",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162652.pdf",
   "indications": "For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use. For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles, For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 6
  },
  {
   "id": "K171647",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-10-23",
   "date_received": "2017-06-05",
   "applicant": "Infinitus (China) Company , Ltd.",
   "device_name": "BeneLife Premium Facial Treatment Pack, Model: QZ0701A",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171647",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171647.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K172181",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-10-13",
   "date_received": "2017-07-19",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "micro IPL",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172181",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172181.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K161434",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-09-28",
   "date_received": "2016-05-24",
   "applicant": "Li-Tek Electronics Technologies",
   "device_name": "Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161434",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161434.pdf",
   "indications": "The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use. LED functional mode - To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face. - To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne. Vibrating massage functional mode As an electrically powered device intended for medical purposes to relieve minor aches and pains.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K171323",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-09-01",
   "date_received": "2017-05-05",
   "applicant": "Biophotas, Inc.",
   "device_name": "BIOPHOTAS CELLUMA3",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171323",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171323.pdf",
   "indications": "The BioPhotas Celluma3 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K170984",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-08-23",
   "date_received": "2017-04-03",
   "applicant": "Lg Electronics",
   "device_name": "LG BEAUTY LED MASK",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "KR",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170984",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170984.pdf",
   "indications": "The LG BEAUTY LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K171895",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-08-22",
   "date_received": "2017-06-26",
   "applicant": "Leana Orders, Inc.",
   "device_name": "Grivamax Hair Growth System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171895",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171895.pdf",
   "indications": "The Grivamax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K171433",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-08-11",
   "date_received": "2017-05-15",
   "applicant": "Home Skinovations , Ltd.",
   "device_name": "Silk'n Infinity",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171433",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171433.pdf",
   "indications": null,
   "indications_status": "no text layer"
  },
  {
   "id": "K171386",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-08-07",
   "date_received": "2017-05-11",
   "applicant": "Led Technologies, Inc.",
   "device_name": "dpl SpectraLite",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171386",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171386.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K171390",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-08-03",
   "date_received": "2017-05-11",
   "applicant": "Led Technologies, Inc.",
   "device_name": "dpl II Panel",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171390",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171390.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K171588",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-07-31",
   "date_received": "2017-05-31",
   "applicant": "Carol Cole Company Dba Nuface",
   "device_name": "NuBODY Skin Toning Device",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171588",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171588.pdf",
   "indications": "NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K163137",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-07-12",
   "date_received": "2016-11-09",
   "applicant": "Dermal Photonics Corporation",
   "device_name": "NIRA Beauty Skin Laser",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163137",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163137.pdf",
   "indications": "The NIRA Beauty Skin Laser is indicated for the treatment of periorbital wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K170499",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-06-15",
   "date_received": "2017-02-17",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "sensiLift",
   "product_code": "PAY",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170499",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170499.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K163470",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-06-02",
   "date_received": "2016-12-12",
   "applicant": "Shenzhen Siken 3D Technology Development Co., Ltd.",
   "device_name": "Galvanic Spa, Model: SKB-1405",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163470",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163470.pdf",
   "indications": "The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K170111",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-05-08",
   "date_received": "2017-01-12",
   "applicant": "Pulsaderm, LLC",
   "device_name": "Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170111",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170111.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K170269",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-05-03",
   "date_received": "2017-01-27",
   "applicant": "Oriental Inspiration Limited",
   "device_name": "Hee HR Mini",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170269",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170269.pdf",
   "indications": "HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K170260",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-04-25",
   "date_received": "2017-01-27",
   "applicant": "Oriental Inspiration Limited",
   "device_name": "BC-001+ Acne Purifier",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170260",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170260.pdf",
   "indications": "BC-001+ Acne Purifier is intended/indicated for over-the-counter use in the treatment of mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K163329",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-04-14",
   "date_received": "2016-11-28",
   "applicant": "Pulsaderm, LLC",
   "device_name": "Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163329",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163329.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K162782",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-04-04",
   "date_received": "2016-10-03",
   "applicant": "Slinph Technologies Co., Ltd.",
   "device_name": "iHelmet Hair Growth System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162782",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162782.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K162784",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-03-25",
   "date_received": "2016-10-03",
   "applicant": "Home Skinovations , Ltd.",
   "device_name": "Silk'n HST",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162784",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162784.pdf",
   "indications": "The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K161428",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-03-23",
   "date_received": "2016-05-23",
   "applicant": "Shen Zhen Cosbeauty Co., Ltd.",
   "device_name": "PerfectSmooth",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161428",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161428.pdf",
   "indications": "The PerfectSmooth is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K163552",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-03-03",
   "date_received": "2016-12-19",
   "applicant": "Cyden Limited",
   "device_name": "iPulse SmoothSkin BARE Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163552",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163552.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K161484",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-02-24",
   "date_received": "2016-05-31",
   "applicant": "Ziip,Llc",
   "device_name": "ZIIP Device",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161484",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161484.pdf",
   "indications": "The ZIIP Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K162071",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-02-24",
   "date_received": "2016-07-27",
   "applicant": "Eglobal, LLC",
   "device_name": "IllumiFlow Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162071",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162071.pdf",
   "indications": "The illumiflow Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 5
  },
  {
   "id": "K163173",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-02-08",
   "date_received": "2016-11-14",
   "applicant": "Liaoning Sidey Optoelectronics Technologies Co., Ltd.",
   "device_name": "Handheld Diode Laser for Hair Removal",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163173",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163173.pdf",
   "indications": "The Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K162106",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-02-03",
   "date_received": "2016-07-29",
   "applicant": "Li-Tek Electronic Technology Corporation",
   "device_name": "Micro-current Wrinkle Reduction Facial service, model EP-400",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162106",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162106.pdf",
   "indications": "The device is intended for facial stimulation by electrode heads for cosmetic use. The device is also intended for the treatment of periorbital wrinkles with red Light Emitting Diode (LED) head. It is for over-the-counter use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K163170",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-01-31",
   "date_received": "2016-11-14",
   "applicant": "Capillus, LLC",
   "device_name": "Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163170",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163170.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K162098",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-01-30",
   "date_received": "2016-07-29",
   "applicant": "Li-Tek Electronic Technology Corporation",
   "device_name": "LED Phototherapy Device",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162098",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162098.pdf",
   "indications": "The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 4
  },
  {
   "id": "K162489",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2017-01-13",
   "date_received": "2016-09-07",
   "applicant": "Zhongshan Bisen Plastic Electronic Products Co., Ltd.",
   "device_name": "RED Light Device",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162489",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162489.pdf",
   "indications": "The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K162371",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-12-15",
   "date_received": "2016-08-24",
   "applicant": "Nutra Luxe MD, LLC",
   "device_name": "Pulsaderm ACE-All Blue",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162371",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162371.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K162450",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-11-30",
   "date_received": "2016-09-01",
   "applicant": "Foreo, Inc.",
   "device_name": "ESPADA Acne-Clearing Blue Light Pen",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162450",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162450.pdf",
   "indications": "The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K162994",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-11-18",
   "date_received": "2016-10-27",
   "applicant": "Capillus, LLC",
   "device_name": "Capillus302, Capillus312, Capillus352",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162994",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162994.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K162231",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-11-16",
   "date_received": "2016-08-08",
   "applicant": "Cyden Limited",
   "device_name": "iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162231",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162231.pdf",
   "indications": "The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K161941",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-10-19",
   "date_received": "2016-07-15",
   "applicant": "Nutra Luxe MD, LLC",
   "device_name": "Pulsaderm Acne Device",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161941",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161941.pdf",
   "indications": "Pulsaderm Acne Device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K161875",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-09-30",
   "date_received": "2016-07-08",
   "applicant": "Transdermal Cap, Inc.",
   "device_name": "LaserCap300, LaserCap224, LaserCap120, LaserCap80",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161875",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161875.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 4,
   "indications_withheld": "LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig‐Savin Classifications of I‐ II, males with androgenetic alopecia who have Hamilton‐Norwood classifications Ila‐Vand for both genders, Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K160728",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-09-16",
   "date_received": "2016-03-16",
   "applicant": "Nutra Luxe MD, LLC",
   "device_name": "NutraStim Hair Laser Helmet",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160728",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160728.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 3,
   "indications_withheld": "NutraStim Hair Laser Helmet is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of 11a to V patters of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-1, 11-2, or frontal, both with Fitzpatrick Skin Types I to IV."
  },
  {
   "id": "K161849",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-07-29",
   "date_received": "2016-07-05",
   "applicant": "Tanda Beauty Canada, Inc.",
   "device_name": "Bright",
   "product_code": "OHS",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CA",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161849",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161849.pdf",
   "indications": "The Bright device is intended to be used for the treatment of wrinkles, rhytides and fine lines in the periorbital region.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K161089",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-07-08",
   "date_received": "2016-04-18",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "sensiLight Mini",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161089",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161089.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K160691",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-06-21",
   "date_received": "2016-03-11",
   "applicant": "Zuko, Inc.",
   "device_name": "Acne Light Therapy Wand",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160691",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160691.pdf",
   "indications": "The Acne Light Therapy Wand is indicated to treat mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K160821",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-06-15",
   "date_received": "2016-03-24",
   "applicant": "Tria Beauty, Inc.",
   "device_name": "Tria Sapphire",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160821",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160821.pdf",
   "indications": "The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K161046",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-05-12",
   "date_received": "2016-04-13",
   "applicant": "Theradome, Inc.",
   "device_name": "Laser Helmet LH40-EVO",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161046",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161046.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K160285",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-04-25",
   "date_received": "2016-02-03",
   "applicant": "Capillus, LLC",
   "device_name": "Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160285",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160285.pdf",
   "indications": "The Capillus272 Pro, Capillus272 OfficePro, Capillus82, and Capillus202 are intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V ; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K160968",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-04-14",
   "date_received": "2016-04-06",
   "applicant": "Cyden Limited",
   "device_name": "iPulse SmoothSkin Gold Hair Removal Device",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160968",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160968.pdf",
   "indications": "The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K152199",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-03-23",
   "date_received": "2015-08-06",
   "applicant": "Trophy Skin, Inc.",
   "device_name": "RejuvatoneMD",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152199",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152199.pdf",
   "indications": "The RejuvatoneMD is intended for facial stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K152332",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-02-25",
   "date_received": "2015-08-18",
   "applicant": "Omm Imports Inc Dba Zero Gravity",
   "device_name": "Perfectio LED infrared device",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152332",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152332.pdf",
   "indications": "Perfectio LED infrared device is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K151337",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-02-24",
   "date_received": "2015-05-19",
   "applicant": "Centre Light Solutions, LLC",
   "device_name": "Strialite",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151337",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151337.pdf",
   "indications": "Strialite is an over-the-counter device indicated for use in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K153081",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-02-15",
   "date_received": "2015-10-23",
   "applicant": "Michael Todd, LP",
   "device_name": "Clear Bi-Light",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153081",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K153081.pdf",
   "indications": "The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K150826",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-02-10",
   "date_received": "2015-03-30",
   "applicant": "Nutra Luxe MD, LLC",
   "device_name": "Nutra Face Lift Model PE8050",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150826",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150826.pdf",
   "indications": "The Nutra Face LIFT Model PE8050 device is intended for facial stimulation and indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K152587",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-02-04",
   "date_received": "2015-09-10",
   "applicant": "Dermascalp, LLC",
   "device_name": "DermaScalp Laser Cap",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152587",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152587.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K153618",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-01-19",
   "date_received": "2015-12-18",
   "applicant": "Capillus, LLC",
   "device_name": "Capillus202",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153618",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K153618.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K151662",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2016-01-06",
   "date_received": "2015-06-19",
   "applicant": "Freedom Laser Therapy, Inc.",
   "device_name": "iRestore",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151662",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151662.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 3,
   "indications_withheld": "The iRestore Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I- II, males who have Norwood-Hamilton Classifications of lla- V and for both, Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K152889",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-12-30",
   "date_received": "2015-09-30",
   "applicant": "Biorenew Labs, LLC",
   "device_name": "SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152889",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152889.pdf",
   "indications": "The Sonilase Blue is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris. The Sonilase Blue-UV Clean is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris. The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "DEN150005",
   "pathway": "De Novo",
   "decision_code": "DENG",
   "decision_description": "Unknown",
   "decision_date": "2015-12-18",
   "date_received": "2015-01-16",
   "applicant": "Endymed Medical, Ltd.",
   "device_name": "Newa Skin Therapy System",
   "product_code": "PAY",
   "clearance_type": "Direct",
   "statement_or_summary": "",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN150005",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN150005.pdf",
   "indications": "The EndyMed Newa™ is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.",
   "indications_status": "quoted",
   "indications_page": 1
  },
  {
   "id": "K150077",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-11-25",
   "date_received": "2015-01-14",
   "applicant": "Pretika Corporation",
   "device_name": "SonicLift",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150077",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150077.pdf",
   "indications": "This device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K152019",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-11-16",
   "date_received": "2015-07-21",
   "applicant": "Trophy Skin, Inc.",
   "device_name": "HairMD",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152019",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152019.pdf",
   "indications": null,
   "indications_status": "unclear classification text",
   "indications_page": 3,
   "indications_withheld": "The HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I -II, in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V and for both, Fitzpatrick Classification of Skin Phototypes of l-IV."
  },
  {
   "id": "K151336",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-10-23",
   "date_received": "2015-05-19",
   "applicant": "Led Intellectual Properties, LLC",
   "device_name": "LightStim Professional 2-Panel Light",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151336",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151336.pdf",
   "indications": "The LightStim Professional System #3A panel is intended for the use in the treatment of full-face wrinkles. The LightStim Professional System #3B panel is intended for the use in the treatment of mild to moderate acne. The LightStim Professional System #4 panel is intended for the use in the treatment of mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K151516",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-08-21",
   "date_received": "2015-06-05",
   "applicant": "Capillus, LLC",
   "device_name": "Capillus82",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K151516",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151516.pdf",
   "indications": "The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K150370",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-07-22",
   "date_received": "2015-02-13",
   "applicant": "Nutra Luxe MD, LLC",
   "device_name": "Nutra Light Advanced",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150370",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150370.pdf",
   "indications": null,
   "indications_status": "unconfirmed words",
   "indications_page": 3,
   "indications_withheld": "Nutra Light Advanced is intended/indicated for over the counter use for the treatment of mild to moderate acne and for the treatment of periorbital wrinkles and rythides.",
   "indications_odd": [
    "rythides"
   ]
  },
  {
   "id": "K150613",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-07-22",
   "date_received": "2015-03-10",
   "applicant": "Transdermal Cap, Inc.",
   "device_name": "LaserCap LC Pro and LC Elite",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150613",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150613.pdf",
   "indications": "The LC PRO and LC ELITE are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K142845",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-07-01",
   "date_received": "2014-09-30",
   "applicant": "Wuhan Lotuxs Technology Co., Ltd.",
   "device_name": "SILKPRO laser hair removal system",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142845",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142845.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K143003",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-06-18",
   "date_received": "2014-10-20",
   "applicant": "Ipulse Limited",
   "device_name": "iPulse Smooth Skin Gold Hair Removal System",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143003",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K143003.pdf",
   "indications": "The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K150578",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-06-09",
   "date_received": "2015-03-09",
   "applicant": "Capillus, LLC",
   "device_name": "Capillus 272 Office Pro",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150578",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150578.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K142794",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-06-02",
   "date_received": "2014-09-29",
   "applicant": "Everyway Medical Instruments Co.,Ltd",
   "device_name": "Everyway Facial MENS",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "TW",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142794",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142794.pdf",
   "indications": "The Everyway Facial MENS, model: MT-200 is intended for facial stimulation and indicated for over-the-counter cosmetic use.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K142824",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-04-14",
   "date_received": "2014-09-30",
   "applicant": "Hairlabs International, Inc.",
   "device_name": "LX-100 Hair Growth Stimulation System",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142824",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142824.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K150098",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-04-09",
   "date_received": "2015-01-20",
   "applicant": "Led Intellectual Properties, LLC",
   "device_name": "LightStim Professional 2-Panel Light",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150098",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150098.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K141181",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-03-31",
   "date_received": "2014-05-07",
   "applicant": "Led Technologies, LLC",
   "device_name": "NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141181",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141181.pdf",
   "indications": "The Nüve for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K142246",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-01-29",
   "date_received": "2014-08-14",
   "applicant": "Led Intellectual Properties, LLC",
   "device_name": "LightStim for Acne/ LightStim for Acne Mini",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142246",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142246.pdf",
   "indications": "LightStim for Acne/ LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K143199",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-01-29",
   "date_received": "2014-11-06",
   "applicant": "Capillus, LLC",
   "device_name": "Capillus 272 Pro",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K143199",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K143199.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K140471",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-01-15",
   "date_received": "2014-02-25",
   "applicant": "La Lumiere, LLC",
   "device_name": "PRO X OTC 5",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140471",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140471.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K141588",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-01-08",
   "date_received": "2014-06-13",
   "applicant": "Nutra Luxe MD, LLC",
   "device_name": "NUTRA STIM HAIR LASER COMB",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141588",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141588.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K141596",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2015-01-08",
   "date_received": "2014-06-13",
   "applicant": "Nutra Luxe MD, LLC",
   "device_name": "NUTRA STIM HAIR LASER COMB",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141596",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141596.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K140931",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-12-05",
   "date_received": "2014-04-11",
   "applicant": "Apira Science, Inc.",
   "device_name": "IGROW II HAIR GROWTH SYSTEM",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140931",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140931.pdf",
   "indications": "The igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K142573",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-12-01",
   "date_received": "2014-09-12",
   "applicant": "Lexington International, LLC",
   "device_name": "HairMax LaserComb, HairMax LaserComb",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142573",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142573.pdf",
   "indications": "The HairMax LaserComb 41 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV. The HairMax LaserComb 82 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K133896",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-11-13",
   "date_received": "2013-12-20",
   "applicant": "Trophy Skin, Inc.",
   "device_name": "REJUVALITE MD",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133896",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133896.pdf",
   "indications": "The Rejuvalite MD is an Over the Counter device that is intended for the use in the treatment of full face wrinkles.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K141242",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-10-17",
   "date_received": "2014-05-14",
   "applicant": "Home Skinovations , Ltd.",
   "device_name": "GLIDE DEVICE",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141242",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141242.pdf",
   "indications": null,
   "indications_status": "no text layer"
  },
  {
   "id": "K141567",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-08-21",
   "date_received": "2014-06-12",
   "applicant": "Apira Science, Inc.",
   "device_name": "IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141567",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141567.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K141308",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-08-20",
   "date_received": "2014-05-19",
   "applicant": "Nutra Luxe MD, LLC",
   "device_name": "NUTRA LIGHT RED",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141308",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141308.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K132518",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-08-17",
   "date_received": "2013-08-12",
   "applicant": "Wellquest Intl., Inc.",
   "device_name": "NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132518",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132518.pdf",
   "indications": "The Wellquest NuBrilliance Pulsed Light Hair Removal system device is an over-the-counter device intended for the removal of unwanted hair. The NuBrilliance Pulsed Light Hair Removal System is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9,a nd 12 months after the completion of the treatment regimen.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K140381",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-08-08",
   "date_received": "2014-02-14",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "SENSILIGHT/ SENSILIGHT PLUS",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140381",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140381.pdf",
   "indications": "The sensiLight™/sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.",
   "indications_status": "quoted",
   "indications_page": 3
  },
  {
   "id": "K133546",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-08-06",
   "date_received": "2013-11-19",
   "applicant": "Ps Advanced Engineering",
   "device_name": "STARLITE-OM, LIGHT EFFECTS, THIBIANT",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133546",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133546.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K140527",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-07-31",
   "date_received": "2014-03-04",
   "applicant": "El Global Trade, Ltd.",
   "device_name": "SENSILIGHT MINI",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140527",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140527.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 8,
   "indications_withheld": "The sensiLight Mini is an over the counter device intended for the removai of unwanted hair. The sensiLight Mini isalso intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen."
  },
  {
   "id": "K132833",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-06-17",
   "date_received": "2013-09-10",
   "applicant": "Accord Media",
   "device_name": "ULTRA RENEW PLUS",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132833",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132833.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K132838",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-05-23",
   "date_received": "2013-09-10",
   "applicant": "Nutra Luxe MD, LLC",
   "device_name": "NUTRA LIGHT BLUE",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132838",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132838.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 6,
   "indications_withheld": "The Nutra Light Blue is a non-invasive LED light device is indicated for over- the -counter use for the treatment of mild to moderate inflammatory acne."
  },
  {
   "id": "K130065",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-04-30",
   "date_received": "2013-01-10",
   "applicant": "Biosonic Technologies, LLC",
   "device_name": "BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130065",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K130065.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The Beautiful Image Model 900 Facial Toning Device uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes. INTENDED USE: Biosonic Technologies Model 900 Facial Toning Device is intended for facial stimulation and is indicated for prescription cosmetic use. The anatomical site for application of the Model 900 is the face."
  },
  {
   "id": "K133823",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-04-17",
   "date_received": "2013-12-17",
   "applicant": "Carol Cole Company",
   "device_name": "NUFACE MINI DEVICE",
   "product_code": "NFO",
   "clearance_type": "Abbreviated",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133823",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133823.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 9,
   "indications_withheld": "The NuFACE®E Mini Facial Toning device is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21I CFR 807 Subpart C)."
  },
  {
   "id": "K132613",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-02-05",
   "date_received": "2013-08-21",
   "applicant": "Biorenew Labs, LLC",
   "device_name": "SONILASE LIGHT THERAPY DEVICE",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132613",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132613.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K133473",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-01-15",
   "date_received": "2013-11-12",
   "applicant": "Cynosure, Inc.",
   "device_name": "ILUMINAGE SKIN SMOOTHING LASER",
   "product_code": "OHS",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133473",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133473.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The Iluminage Skin Smoothing Laser is indicated for use in the treatment of periorbital and periaral wrinkles."
  },
  {
   "id": "K131461",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2014-01-06",
   "date_received": "2013-05-20",
   "applicant": "Led Intellectual Properties, LLC",
   "device_name": "LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131461",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131461.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "LightStin for Acne Mini,. model: LS4AM is intended for OverThe-Counter use for the treatment of mild to moderate acne."
  },
  {
   "id": "K132646",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-12-20",
   "date_received": "2013-08-26",
   "applicant": "Sunetics International Marketing Group, LLC",
   "device_name": "SUNETICS CLINICAL BIO-STIMULATION LASER",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132646",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132646.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K124064",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-12-19",
   "date_received": "2012-12-31",
   "applicant": "Espansione Marketing S.P.A",
   "device_name": "YOUNG AGAIN",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IT",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K124064",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K124064.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The Young Again is an over the counter device intended to emit energy in the red and IRregion of the spectrum for use in dermatology for treatment of periorbital wrinkles."
  },
  {
   "id": "K131251",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-10-01",
   "date_received": "2013-05-01",
   "applicant": "Carol Cole Company",
   "device_name": "TRINITY ELE",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131251",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131251.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 1,
   "indications_withheld": "The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C)."
  },
  {
   "id": "K122711",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-09-17",
   "date_received": "2012-09-04",
   "applicant": "Nuskin",
   "device_name": "FACIAL SPA",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122711",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K122711.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 1,
   "indications_withheld": "The Facial Spa is indicated for facial stimulation for over-the-counter cosmetic use."
  },
  {
   "id": "K123999",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-08-28",
   "date_received": "2012-12-26",
   "applicant": "La Lumiere, LLC",
   "device_name": "ILLUMASK ACNE LIGHT THERAPY MASK",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K123999",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K123999.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K131870",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-08-14",
   "date_received": "2013-06-24",
   "applicant": "Home Skinovations , Ltd.",
   "device_name": "GLIDE DEVICE",
   "product_code": "OHT",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131870",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131870.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K130315",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-07-12",
   "date_received": "2013-02-08",
   "applicant": "Cyden Limited",
   "device_name": "IPULSE HAIR REMOVAL SYSTEM",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "GB",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130315",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K130315.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 5,
   "indications_withheld": "The Pulse Hair Removal System is an over-the-counter device intended for removal of unwanted hair."
  },
  {
   "id": "K130225",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-07-11",
   "date_received": "2013-01-29",
   "applicant": "Silverbay, LLC, D/B/A Quasar Bio-Tech",
   "device_name": "QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130225",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K130225.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 9,
   "indications_withheld": "The Quasar C100 Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of full-face wrinkles. The Baby Quasar Plus Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of fullface wrinkles. The Quasar MD Plus Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of fullface wrinkles."
  },
  {
   "id": "K121920",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-06-27",
   "date_received": "2012-07-02",
   "applicant": "Sunetics International Marketing Group, LLC",
   "device_name": "LASERBRUSH",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121920",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121920.pdf",
   "indications": null,
   "indications_status": "no text layer"
  },
  {
   "id": "K122950",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-06-14",
   "date_received": "2012-09-25",
   "applicant": "Theradome, Inc.",
   "device_name": "LASER HELMET",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122950",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K122950.pdf",
   "indications": null,
   "indications_status": "no text layer"
  },
  {
   "id": "K124042",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-04-02",
   "date_received": "2012-12-28",
   "applicant": "Syneron Beauty",
   "device_name": "TANDA MINI SKINCARE SYSTEM",
   "product_code": "OLP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K124042",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K124042.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The Tanda Mini Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne."
  },
  {
   "id": "K121435",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2013-02-22",
   "date_received": "2012-05-14",
   "applicant": "Home Skinovations , Ltd.",
   "device_name": "SILKN BLUE",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121435",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121435.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 1,
   "indications_withheld": "The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne."
  },
  {
   "id": "K122248",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-12-05",
   "date_received": "2012-07-27",
   "applicant": "Apira Science, Inc.",
   "device_name": "IGROW II HAIR GROWTH SYSTEM",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122248",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K122248.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 7,
   "indications_withheld": "The igrow-Il Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V and Fitzpatrick Classification of Skin Phototypes I to IV."
  },
  {
   "id": "K120560",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-11-06",
   "date_received": "2012-02-24",
   "applicant": "Carol Cole Company",
   "device_name": "TRINITY WRINKLE REMOVER",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120560",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K120560.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K122280",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-10-23",
   "date_received": "2012-07-30",
   "applicant": "Cyden Limited",
   "device_name": "IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122280",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K122280.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 1,
   "indications_withheld": "The iPulse SmoothSkin Hair Removal System is indicated for the removal of unwanted hair."
  },
  {
   "id": "K112362",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-08-14",
   "date_received": "2011-08-17",
   "applicant": "Silver Bay, LLC",
   "device_name": "C100 WRINKLE REDUCTION DEVICE",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112362",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K112362.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 8,
   "indications_withheld": "The Quasar C1 00 Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of periorbitaL wrinkles."
  },
  {
   "id": "K120511",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-07-30",
   "date_received": "2012-02-21",
   "applicant": "Leto Enterprise , Ltd.",
   "device_name": "AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "HK",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120511",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K120511.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 8,
   "indications_withheld": "Ageless Wonder Facial Muscle Stimulation System is intended for facial stimulation and is indicated for over-the-counter cosmetic use."
  },
  {
   "id": "K111454",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-07-05",
   "date_received": "2011-05-25",
   "applicant": "Cynosure, Inc.",
   "device_name": "ILUMINAGE DIODE LASER",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111454",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K111454.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 4,
   "indications_withheld": "The Iluminage laser device is indicated for use in the treatment of periorbital and perioral wrinkles."
  },
  {
   "id": "K120775",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-06-04",
   "date_received": "2012-03-14",
   "applicant": "Led Intellectual Properties, LLC",
   "device_name": "LIGHT FOR WRINKLES",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120775",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf12/K120775.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The Lighitimn for Wrinkles is an Over-The-Counter handheld device intended for the use in the treatment of full-face wrinkles."
  },
  {
   "id": "K112351",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-03-30",
   "date_received": "2011-08-16",
   "applicant": "Johari Digital Healthcare , Ltd.",
   "device_name": "ULTRA BEAUTY",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IN",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112351",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K112351.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K113097",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-03-02",
   "date_received": "2011-10-19",
   "applicant": "Theradome, Inc.",
   "device_name": "LASER HELMET",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113097",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K113097.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 5,
   "indications_withheld": "The Theradome Laser Helmet LH8O PRO is a prescription use therapeutic device indicate d to promote hair growth in females, with androgenic alopecia, having Ludwig and Savin Hair Loss Scale classification 1-Il and Fitzpatrick Skin-Types I to IV."
  },
  {
   "id": "K111341",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-02-29",
   "date_received": "2011-05-12",
   "applicant": "Medicon Co., Ltd.",
   "device_name": "CLEANE / CLEANE POP",
   "product_code": "OZC",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111341",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K111341.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 5,
   "indications_withheld": "The CLEANE and the CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne."
  },
  {
   "id": "K113724",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-02-15",
   "date_received": "2011-12-19",
   "applicant": "Pain Relief Technologies",
   "device_name": "ELECTROPULSE-COSMETIC",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Statement",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K113724",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K113724.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K111937",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-02-08",
   "date_received": "2011-07-08",
   "applicant": "Clearflash Technologies, Inc.",
   "device_name": "CLEARFLASH AC2100 COSMETIC SYSTEM",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111937",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K111937.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The ClearFlash AC2100 Cosmetic System is indicated for the treatment of individual acne pimpl~es in persons with mild to moderate inflammatory acne."
  },
  {
   "id": "K111286",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2012-01-18",
   "date_received": "2011-05-06",
   "applicant": "Silver Bay, LLC",
   "device_name": "QUASAR CALYPSO",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111286",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K111286.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 6,
   "indications_withheld": "The Quasar Calypso C50 is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris."
  },
  {
   "id": "K102494",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2011-12-09",
   "date_received": "2010-08-31",
   "applicant": "Daka International , Ltd.",
   "device_name": "THE BUZZ FACIAL TONING SYSTEM",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102494",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf10/K102494.pdf",
   "indications": null,
   "indications_status": "no text layer"
  },
  {
   "id": "K103031",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2011-11-10",
   "date_received": "2010-10-12",
   "applicant": "Bio-Medical Research, Ltd.",
   "device_name": "BMR FACE",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IE",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103031",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf10/K103031.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K103472",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2011-11-07",
   "date_received": "2010-11-24",
   "applicant": "Carol Cole Company",
   "device_name": "NUFACE PLUS",
   "product_code": "NFO",
   "clearance_type": "Abbreviated",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103472",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf10/K103472.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K112524",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2011-09-26",
   "date_received": "2011-08-31",
   "applicant": "Lexington International, LLC",
   "device_name": "HAIRMAX LASERCOMB",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112524",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K112524.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 1,
   "indications_withheld": "The HairMax LaserComb Advanced 7 is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-i1, 112, or frontal and Fitzpatrick Skin Types I to IV. The HairMax LaserComb Professional 12 is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-1, 11-2, or frontal and Fitzpatrick Skin Types I to IV."
  },
  {
   "id": "K110301",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2011-08-19",
   "date_received": "2011-02-02",
   "applicant": "Home Skinovations , Ltd.",
   "device_name": "SILK'N FX",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110301",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K110301.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 1,
   "indications_withheld": "Silkn FX is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles."
  },
  {
   "id": "K111714",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2011-08-16",
   "date_received": "2011-06-20",
   "applicant": "Lexington International, LLC",
   "device_name": "HAIRMAX DUAL 12",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111714",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K111714.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The HairMax Dual 12 is indicated to Treat Androgenetic Alopecia and Promote Hair Growth in Females who have Ludwig (Savin) Scale 1-4, H1-, 11-2, or frontal and Fitzpatrick Skin Types I to IV."
  },
  {
   "id": "K110735",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2011-08-03",
   "date_received": "2011-03-16",
   "applicant": "Pharos Life Corporation",
   "device_name": "TANDA MAX OTC SYSTEM",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110735",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K110735.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 5,
   "indications_withheld": "Thinda Max OTC is intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region."
  },
  {
   "id": "K110233",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2011-05-27",
   "date_received": "2011-01-26",
   "applicant": "Lexington International, LLC",
   "device_name": "HAIRMAX LASERCOMB",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110233",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf11/K110233.pdf",
   "indications": null,
   "indications_status": "no document"
  },
  {
   "id": "K103368",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2011-04-06",
   "date_received": "2010-11-17",
   "applicant": "Lexington International, LLC",
   "device_name": "HAIRMAX LASERCOMB",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103368",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf10/K103368.pdf",
   "indications": null,
   "indications_status": "no text layer"
  },
  {
   "id": "K103184",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2010-11-10",
   "date_received": "2010-10-29",
   "applicant": "Home Skinovations , Ltd.",
   "device_name": "SILK'N FLASH N GO",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103184",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf10/K103184.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K101382",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2010-11-09",
   "date_received": "2010-05-17",
   "applicant": "Led Technologies, LLC",
   "device_name": "DPL NUVE",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101382",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf10/K101382.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 1,
   "indications_withheld": "Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne."
  },
  {
   "id": "K102477",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2010-10-04",
   "date_received": "2010-08-30",
   "applicant": "Radiancy (Israel) , Ltd.",
   "device_name": "NO!NO! SKIN",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "IL",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K102477",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf10/K102477.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 6,
   "indications_withheld": "The nolno! SkinTM is intended to provide phototherapeutic light and heat to the body and is generally indicated to treat dermatological conditions. It is specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne."
  },
  {
   "id": "K093963",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2010-08-27",
   "date_received": "2009-12-23",
   "applicant": "Silver Bay, LLC",
   "device_name": "QUASAR BLUE LIGHT THERAPY SYSTEM",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093963",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf9/K093963.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 1,
   "indications_withheld": "The \"Quasar Blue\" Blue Light Therapy System is intended to provide photo therapeutic light to the body. The 'Quasar Blue\" Blue Light Therapy System is generally indicated to treat dermatological conditions. The 'Quasar Blue\" Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat mild to moderate inflammatory acne vulgaris."
  },
  {
   "id": "K101190",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2010-07-01",
   "date_received": "2010-04-28",
   "applicant": "Led Intellectual Properties, LLC",
   "device_name": "LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101190",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf10/K101190.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 6,
   "indications_withheld": "The Light for Winkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles."
  },
  {
   "id": "K090744",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2010-04-15",
   "date_received": "2009-03-20",
   "applicant": "Clrs Technology Corporation",
   "device_name": "CLARO",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090744",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf9/K090744.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne."
  },
  {
   "id": "K092460",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2010-03-05",
   "date_received": "2009-08-11",
   "applicant": "Ps Advanced Engineering",
   "device_name": "STAR-LITE -LM, MODEL SL8809",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092460",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf9/K092460.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K091496",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2010-02-23",
   "date_received": "2009-05-20",
   "applicant": "Midwest Rf, LLC",
   "device_name": "MEP-90 HAIR GROWTH STIMULATION SYSTEM",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K091496",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf9/K091496.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K093499",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2009-11-23",
   "date_received": "2009-11-12",
   "applicant": "Lexington International, LLC",
   "device_name": "HAIRMAX LASERCOMB",
   "product_code": "OAP",
   "clearance_type": "Special",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093499",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf9/K093499.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The HairMax LaserComb is indicated to promote hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV."
  },
  {
   "id": "K081307",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2009-01-16",
   "date_received": "2008-05-08",
   "applicant": "Photo Therapeutics, Inc.",
   "device_name": "OMNILUX CLEAR-U",
   "product_code": "OLP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081307",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf8/K081307.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K071573",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2008-12-09",
   "date_received": "2007-06-08",
   "applicant": "Fatrotek S.R.L.",
   "device_name": "RUGALIFT, MODEL# V.2.1",
   "product_code": "NFO",
   "clearance_type": "Abbreviated",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "CH",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071573",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf7/K071573.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K070250",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2008-09-04",
   "date_received": "2007-01-26",
   "applicant": "Isomers Laboratories, Inc.",
   "device_name": "NUTRITONE FACIAL BEAUTY SYSTEM",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070250",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf7/K070250.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K070217",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2008-04-04",
   "date_received": "2007-01-23",
   "applicant": "Neuro Resource Group, Inc.",
   "device_name": "INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070217",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf7/K070217.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 1,
   "indications_withheld": "This device is intended for cosmetic use."
  },
  {
   "id": "K072459",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2008-03-03",
   "date_received": "2007-08-31",
   "applicant": "Photo Therapeutics, Inc.",
   "device_name": "OMNILUX NEW-U",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072459",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf7/K072459.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles."
  },
  {
   "id": "K062991",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2008-02-15",
   "date_received": "2006-09-29",
   "applicant": "Light Bioscience, LLC",
   "device_name": "GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE",
   "product_code": "OHS",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K062991",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf6/K062991.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K072260",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2007-11-27",
   "date_received": "2007-08-14",
   "applicant": "Carol Cole Company",
   "device_name": "NUFACE, MODEL NU-4003",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072260",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf7/K072260.pdf",
   "indications": null,
   "indications_status": "not located in document"
  },
  {
   "id": "K060305",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2007-01-18",
   "date_received": "2006-02-06",
   "applicant": "Lexington International, LLC",
   "device_name": "HAIRMAX LASERCOMB",
   "product_code": "OAP",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K060305",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf6/K060305.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of la to V and Fitzpatrick Skin Types I to IV."
  },
  {
   "id": "K060839",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2006-12-07",
   "date_received": "2006-03-28",
   "applicant": "Palomar Medical Technologies, Inc.",
   "device_name": "ABC HAIR REMOVAL SYSTEM",
   "product_code": "OHT",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K060839",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf6/K060839.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 2,
   "indications_withheld": "The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments."
  },
  {
   "id": "K040871",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2005-06-01",
   "date_received": "2004-04-02",
   "applicant": "Facemaster of Beverly Hills, Inc.",
   "device_name": "FACEMASTER FACIAL TONING SYSTEM",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040871",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf4/K040871.pdf",
   "indications": null,
   "indications_status": "scanned page",
   "indications_page": 5,
   "indications_withheld": "The FaceMaster® Facial Toning System is intended to stimulate the face. The device is indicated for cosmetic use."
  },
  {
   "id": "K011935",
   "pathway": "510(k)",
   "decision_code": "SESE",
   "decision_description": "Substantially Equivalent",
   "decision_date": "2001-08-08",
   "date_received": "2001-06-21",
   "applicant": "Salton, Inc.",
   "device_name": "REJUVENIQUE MODEL #RJV10",
   "product_code": "NFO",
   "clearance_type": "Traditional",
   "statement_or_summary": "Summary",
   "third_party": false,
   "country_code": "US",
   "database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K011935",
   "document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf/K011935.pdf",
   "indications": null,
   "indications_status": "no text layer"
  }
 ]
}