Beijing Stelle Laser Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Dermatological diode laser 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 Dermatological diode laser 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 Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot-switch. The laser light targets melanin and treats selectively in a precise way. Melanin absorbs the energy from the laser, resulting in a rapid temperature increase that destroys germinal cells without damaging the epidermis and surrounding normal tissue. After laser exposure, the debris of these cells is removed from the body by phagocytic cells. The four models of different products produced by our company are consistent in Wavelength, Energy Fluence, Pulse Duration, Energy deviation, Spot Size, Frequency, and so on. It's just that the shell is slightly different.
Summary parsed at:2026-06-01 05:38:28 UTC
Diode Laser Hair Removal System
K212478 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K212478 as a predicate
