Gu'An Yeolight Smart Electronics Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.
The IPL Hair Removal Device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a main unit, power adapter and protective goggles. The device contains a skin sensor to detect appropriate skin contact; if the light emitting window is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature by the Sapphire and provide the user with a better using experience. There are SYL001AZ and SYL002AZ two models in this application. Their work principle, function, intended use, structure, appearance and composition are the same, with the only difference in treatment level.
Summary parsed at:2026-06-11 04:32:34 UTC
