Shenzhen Mlay Intelligent Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The IPL Hair Removal Device is an over-the-counter device 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 amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The IPL Hair Removal Device is an over-the-counter device 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 amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The IPL Hair Removal Device (Models: T31A, T32A) is designed with dual lamps that work together and can emit multiple pulses per shot. It features an auto-recognition skin color mode, where a skin tone sensor detects and identifies the color of skin to determine the required intensity based on the recognized skin color. The device includes a cooling technology based on the temperature difference electrical phenomenon through a semiconductor cooling chip, utilizing the Peltier effect for cooling. The cooling panel is constructed with sapphire and does not affect the irradiated area (spot size) of the light outlet.
Summary parsed at:2026-06-11 04:25:19 UTC
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
K253666 references 2 predicate/reference devices
No later 510(k)s cite this device yet
Other submissions will appear here when they list K253666 as a predicate
