The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.
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.”
“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.”
“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.”
“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.”
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“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.”