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 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.”
“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.”
“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.”