Smart Beauty Devices: newest FDA records The 30 newest 510(k) and De Novo records in the 8 beauty device product codes we cover, by FDA decision date. Snapshot fetched October 12, 2026. https://smartbeautydevices.com/new/ 2026-10-12T00:00:00Z North Coast AI LLC Braun Aura 9 (6042) (K261977)https://smartbeautydevices.com/r/K2619772026-10-12T00:00:00Z510(k) cleared. FDA decision date: Sep 25, 2026. Filed by Cyden Limited. Product code OHT. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) (K262183)https://smartbeautydevices.com/r/K2621832026-10-12T00:00:00Z510(k) cleared. FDA decision date: Sep 24, 2026. Filed by Shenzhen Nuon Medical Equipment Co., Ltd.. Product code OAP. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Hair Growth Comb (X-GC01) (K262254)https://smartbeautydevices.com/r/K2622542026-10-12T00:00:00Z510(k) cleared. FDA decision date: Sep 23, 2026. Filed by Guangdong Ashmore Health Technology Co., Ltd.. Product code OAP. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524)https://smartbeautydevices.com/r/K2625242026-10-12T00:00:00Z510(k) cleared. FDA decision date: Sep 18, 2026. Filed by ONE BEAUTY Technology Co., Ltd.. Product code OHT. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (K261370)https://smartbeautydevices.com/r/K2613702026-10-12T00:00:00Z510(k) cleared. FDA decision date: Sep 16, 2026. Filed by Guangdong Newdermo Biotech Co., Ltd.. Product code NFO. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. PureLift Pro Max (K262861)https://smartbeautydevices.com/r/K2628612026-10-12T00:00:00Z510(k) cleared. FDA decision date: Sep 11, 2026. Filed by Xtreem Pulse, LLC. Product code NFO. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) (K260387)https://smartbeautydevices.com/r/K2603872026-10-12T00:00:00Z510(k) cleared. FDA decision date: Aug 31, 2026. Filed by Hironic Co., Ltd.. Product code NFO. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. 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) (K260767)https://smartbeautydevices.com/r/K2607672026-10-12T00:00:00Z510(k) cleared. FDA decision date: Aug 31, 2026. Filed by Kam Yuen Plastic Products , Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Eye Recovery Pro (PH-e03) (K261602)https://smartbeautydevices.com/r/K2616022026-10-12T00:00:00Z510(k) cleared. FDA decision date: Aug 10, 2026. Filed by Shenzhen Goodwind Technology Development Co., Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Hair Removal Device (R3C16-G Pro, R3C16-V Pro) (K261705)https://smartbeautydevices.com/r/K2617052026-10-12T00:00:00Z510(k) cleared. FDA decision date: Aug 10, 2026. Filed by Shenzhen Jianchao Intelligent Technology Co., Ltd.. Product code OHT. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) (K261601)https://smartbeautydevices.com/r/K2616012026-10-12T00:00:00Z510(k) cleared. FDA decision date: Aug 7, 2026. Filed by Shenzhen Chuangtong Yigou Technology Co., Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. LED Light Therapy Masks (PE748, PE749, PE756) (K261496)https://smartbeautydevices.com/r/K2614962026-10-12T00:00:00Z510(k) cleared. FDA decision date: Aug 4, 2026. Filed by Duplex International Trading Limited. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. 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) (K261851)https://smartbeautydevices.com/r/K2618512026-10-12T00:00:00Z510(k) cleared. FDA decision date: Aug 4, 2026. Filed by Shenzhen Qianyu Technology Co., Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. LightStim for Wrinkles (1984); LightStim for Acne (2038) (K261482)https://smartbeautydevices.com/r/K2614822026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jul 31, 2026. Filed by Led Intellectual Properties, LLC. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. 5 Wavelength LED Facemask (TN2508) (K260598)https://smartbeautydevices.com/r/K2605982026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jul 24, 2026. Filed by iSMART Developments, Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. FACEGYM Pro Device (HD-109) (K253932)https://smartbeautydevices.com/r/K2539322026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jul 23, 2026. Filed by Shenzhen Kaiyan Medical Equipment Co., Ltd.. Product code NFO. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) (K261675)https://smartbeautydevices.com/r/K2616752026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jul 17, 2026. Filed by Shenzhen Chuanghong Zhilian Technology Co., Ltd.. Product code OAP. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) (K261407)https://smartbeautydevices.com/r/K2614072026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jul 15, 2026. Filed by Dongguan Miqiang Technology Co., Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Chromix (K261473)https://smartbeautydevices.com/r/K2614732026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jul 1, 2026. Filed by Termosalud S.L.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) (K261052)https://smartbeautydevices.com/r/K2610522026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jun 29, 2026. Filed by Guangdong Newdermo Biotech Co., Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. 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) (K261253)https://smartbeautydevices.com/r/K2612532026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jun 26, 2026. Filed by Ziree Co., Ltd.. Product code OAP. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) (K260946)https://smartbeautydevices.com/r/K2609462026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jun 18, 2026. Filed by Guangdong Newdermo Biotech Co., Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) (K253231)https://smartbeautydevices.com/r/K2532312026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jun 16, 2026. Filed by Hubei Yjt Technology Co.,Ltd. Product code OAP. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) (K254025)https://smartbeautydevices.com/r/K2540252026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jun 16, 2026. Filed by Shenzhen Kaiyan Medical Equipment Co., Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) (K260899)https://smartbeautydevices.com/r/K2608992026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jun 16, 2026. Filed by Zdeer Technology (Henan) Co., Ltd.. Product code OAP. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Alma TED+ System (K251684)https://smartbeautydevices.com/r/K2516842026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jun 5, 2026. Filed by Alma Lasers, Inc.. Product code OAP. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. VITA Multi-Function Head Brush (TB-2343F, TB-2442F) (K260179)https://smartbeautydevices.com/r/K2601792026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jun 3, 2026. Filed by Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. Product code NFO. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (K260715)https://smartbeautydevices.com/r/K2607152026-10-12T00:00:00Z510(k) cleared. FDA decision date: Jun 3, 2026. Filed by The Beauty Tech Group, Ltd.. Product code OHS. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Ulike Clear Zero (YC10 BU) (K260895)https://smartbeautydevices.com/r/K2608952026-10-12T00:00:00Z510(k) cleared. FDA decision date: May 28, 2026. Filed by Guangxi Ulike Medical Technology Co., Ltd.. Product code NFO. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale. Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) (K261325)https://smartbeautydevices.com/r/K2613252026-10-12T00:00:00Z510(k) cleared. FDA decision date: May 21, 2026. Filed by Shenzhen Ulike Smart Electronics Co., Ltd.. Product code OHT. From our copy of FDA's database fetched October 12, 2026, covering 8 beauty device product codes; a record is not a verified match to any product on sale.