Wuhan Lotuxs Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Hair Removal is also intended for permanent reduction in hair regrowth defined as a 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.
Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Hair Removal is also intended for permanent reduction in hair regrowth defined as a 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 Diode Laser Hair Removal device models LHR-V8S-810, LHR-V8-810, LHR-V4S-810, and LHR-V4-810 emit pulses of invisible infrared laser light of 810nm 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:2026-06-11 04:38:15 UTC
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K230090 references 1 predicate/reference device
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