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.
Laser and IPL hair removal (mostly over-the-counter; 1 record says prescription use) (OHT, 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
“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.”
“Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes. The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.”