Beijing Superlaser Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Diode Laser 808nm 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 808nm 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 808nm is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. The proposed device has six main function modules: 1. Water cooling system: Achieves heat and cold exchange of air through a refrigeration compressor and a water pump for cooling water cycle. 2. Power system: Provides the size of laser energy according to control requirements. 3. User Interface system: Displays relevant information and allows users to set parameters or functions. 4. Handpiece system: Allows selection of appropriate treatment tools based on treatment methods. 5. Main circuit power supply system: Supplies power to the equipment and controls the power supply. 6. Main circuit control system: Controls the operation sequence of equipment parts and provides fault or warning sounds.
Summary parsed at:2026-06-01 05:55:54 UTC
