Shenzhen Yuwei Electronic Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
The IPL 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 Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the flash window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the flash window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse. There are six models in this application: S1-A, S2-A, S1, S2, S3, and S4. According to the declaration of the manufacturer, the difference of all models is mainly the exception of the product appearance, display contents on the display and the spot size of treatment window which does not affect the intended use. The spot size of model S1-A and S2-A is designed to 3.0cm2, model S1, S2, S3, and S4 is designed to 4.1cm2, as well as the energy density of the all models is in the range of 2.2~5.6J/cm2.
Summary parsed at:2026-06-11 04:30:59 UTC
