Wuhan Lotuxs Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction. Permanent hair reduction is 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 device is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction. Permanent hair reduction is 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 device is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The Diode Laser Hair Removal device models LHR-V6S-1064 and LHR-V6S/B-1064 emit pulses of invisible infrared laser light of 1064nm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.
Summary parsed at:2026-06-01 05:33:14 UTC
DermRays Revive
1 submission cite K232117 as a predicate
