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The 30 newest records in FDA's database for the 8 product codes this site covers, by FDA decision date. Our copy of FDA's data was fetched October 12, 2026; records FDA added later aren't here yet.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 5.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The Sapphire Cooling IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
FDA filed this record under product code NFO (electrical stimulation for aesthetic use), even though its name mentions light. We show it where FDA filed it.
510(k) cleared
“Intended for facial stimulation and indicated for over-the-counter cosmetic use.”
Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.
510(k) cleared
Not quoted here. FDA doesn't host a document for this record at the usual address.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“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 …”
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The FACEGYM Pro Device (Model: HD-109) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”
Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.
510(k) cleared
Names skin types This record's indications for use name Fitzpatrick skin types. Read the full statement below; it may limit who the device is for.
“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).”
Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.
510(k) cleared
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“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 …”
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“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 …”
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 4.
510(k) cleared
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Names skin types This record's indications for use name Fitzpatrick skin types. Read the full statement below; it may limit who the device is for.
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 4.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.