Shenzhen Ulike Smart Electronics Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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 types: Fitzpatrick Skin Types I-V. Treatment area: Large areas (e.g. arms, legs, chest) and small areas (e.g. lip).
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.
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit continuously double or triple pulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
Summary parsed at:2026-06-11 04:27:52 UTC
