Shenzhen Huaruibo Electric Appliances Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
IPL Hair Removal Device is the fast professional IPL with 6 levels for DH4, 8 levels for DH5, DH5 Plus and DH5 Max, and offers a beauty experience in comfort of your own home as well as has been designed with unique features for simple, relaxed and effective hair removal. IPL Hair Removal Devices of models: DH4, DH5, DH5 Plus and DH5 Max consist of IPL host and power adapter. The host is mainly composed of hair removal lamp, power/level button, skin sensor, thermovent (fan), flash button and DC socket. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Devices of models DH5 Plus and DH5 Max have the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
Summary parsed at:2026-06-11 04:47:49 UTC
