Shenzhen Huachuangtong Industrial Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair. Ice Cooling IPL Hair Removal Device with sapphire treatment window 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. Applicable skin Fitzpatrick skin types I-V.
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair. Ice Cooling IPL Hair Removal Device with sapphire treatment window 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.
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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are HCT-1208/HCT-1208B/HCT-1208L 3 models in this application. Their work principle, intended use, structure, appearance, size, and operation are the same, with differences being product function are slight differences, but these parameters are within the
Summary parsed at:2026-06-11 04:30:43 UTC
No later 510(k)s cite this device yet
Other submissions will appear here when they list K251707 as a predicate
