Shenzhen Yang WO Electronic Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
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.
IPL Hair Removal Device is an over-the-counter, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device includes three models with the only difference in enclosure color. It is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact; if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a cooling function for a better hair removal experience.
Summary parsed at:2026-06-11 04:46:50 UTC
IPL Hair Removal Device (BE965A, BE965B, BE965C)
1 submission cite K241834 as a predicate
