Beijing Sano Laser S&T Development Co.,Ltd
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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 Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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 proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types. There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The main components of proposed device include a handpiece to deliver the laser to the area to be treated, a touch screen for user interface and system control, an emergency stop switch to halt the system in emergencies, a key switch to start the system, an LED screen to display working status and set treatment parameters, and a foot switch to control the laser output.
Summary parsed at:2026-06-01 05:46:46 UTC
Diode Laser Therapy Machine
K191970 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K191970 as a predicate
