Records FDA files under its code for light-based over-the-counter wrinkle reduction. Most are LED masks, panels, wands and eye devices; individual records can list other or additional uses.
163 records from 2008 to 2026, filed by 100 companies. 57 of the device names as filed include the word "mask". We quote the indications for use for 81 of them from FDA's PDFs.
What FDA's code OHS covers
FDA device name
“Light Based Over The Counter Wrinkle Reduction”
FDA definition
“Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.”
Physical state
“The device can be hand held or mounted on a support system like a stand or mechanical arm. The device will emit light that can be monochromatic or narrow band or broad band. The light energy may be very low to moderate power levels.”
Technical method
“Uses light based energy delivered to and or through the skin to effect change in the tissue that results in the reduction of wrinkles.”
Target area
“Mostly intended to be used on the human face, head, and neck.”
Regulation
21 CFR 878.4810: “Laser surgical instrument for use in general and plastic surgery and in dermatology.” This regulation covers laser and light instruments for general and plastic surgery and dermatology broadly; the product code is what narrows it to over-the-counter use.
Each record is one FDA decision about the device named in it, for the use in its indications statement. The company that filed may be the brand on the box or the manufacturer that makes it for the brand.
Records are grouped by FDA product code; a record's own indications can be narrower, broader or different from the group name, so read each one. We quote an indications statement only when it comes from a text page of FDA's PDF (not a scan) and every word checks out; otherwise the entry says why and links the PDF, which is the authority.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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 …”
Read the full statement
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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 …”
Read the full statement
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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 …”
Read the full statement
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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 …”
Read the full statement
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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 …”
Read the full statement
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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 …”
Read the full statement
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
Source discrepancy: this statement names “SBK-2109”, which doesn't appear in the device name in FDA's database. Both are shown exactly as FDA's records have them.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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 …”
Read the full statement
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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 …”
Read the full statement
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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 …”
Read the full statement
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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).”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 3.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 3.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 3.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 3.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 3.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 3.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
Source discrepancy: this statement names “OR-01”, which doesn't appear in the device name in FDA's database. Both are shown exactly as FDA's records have them.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 3.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 3.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 2.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 2.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 9.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 8.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 2.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 1.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 1.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 6.
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
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 2.