Shenzhen Mareal Tech Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
The Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. It consists of IPL main device and AC adapter, and a detachable lamp cap located in the IPL main device which is the source of optical radiation, namely a Xenon flashlamp. The Home Use Hair Removal Device includes three models, T1, T2 and T3. All three models are exactly the same with the exception of the LCD display contents (mainly as the symbol of treatment level). T1 and T3 both adopt shape identification to display the treatment levels, which T1 adopts fan-shaped display and T3 adopts rectangle-shaped display. And T2 direct adopts digital symbol to display treatment levels.
Summary parsed at:2026-06-11 04:23:23 UTC
