Shenzhen Wochuan Electronic Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair. The IPL Hair Removal Device OBT-02 Version is indicated for the removal of unwanted hair and for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and months after the completion of a treatment regime. The device is used for adults. Treatment area includes multiple hair removal areas, including small areas (e.g. armpit, bikini lines) and large areas (e.g. arms, legs). The device is designed for use on the legs, underarms, bikini line, chest, stomach, back, arms and on the face below the cheekbones. Removal of unwanted body 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.
IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair. The IPL Hair Removal Device OBT-02 Version is indicated for the removal of unwanted hair and for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 months after the completion of a treatment regime. The device is used for adults.
The IPL Hair Removal device is a handheld device powered by an external power supply. It utilizes Intense Pulsed Light (IPL) technology with a light source of Xenon Arc flashlamp. The device has a wavelength range of 470nm to 1100nm and operates with energy densities varying by model. The device is designed for use on multiple hair removal areas, including small areas (e.g., armpit, bikini lines) and large areas (e.g., arms, legs).
Summary parsed at:2026-06-11 04:41:27 UTC
IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
1 submission cite K232124 as a predicate
