Shenzhen Mismon Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
The Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
The Home Use IPL Beauty 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. The Device includes MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6 and MELSYA-M7 six models. All have adopted the same structure design, consisting of IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. The difference of all models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of model MS-208B, MS-212B and MELSYA-M6 is designed to 3.6cm2, model MS-216B, MS-218B and MELSYA-M7 is designed to 3.0 cm2, as well as the energy density of all models is in the range of 2.0~5.1J/cm2.
Summary parsed at:2026-06-11 04:27:09 UTC
