Guangzhou Huafei Tongda Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The 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 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 proposed device, Diode Laser System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). The device includes a control panel that uses a microcontroller and an LCD screen for human-machine interaction, allowing the operator to set device parameters and control the output laser energy. The main control module receives laser energy parameters and work instructions, detects the footswitch state, and monitors temperature, humidity, liquid level, and flow during operation. The constant current board module supplies the semiconductor laser with a constant drive current and has detection functions for over-current, over-voltage, and over-temperature. The temperature and humidity control system includes a condenser, cold plate, and fans to maintain optimal conditions during operation. The handpiece module is the execution unit of the device, composed of a semiconductor laser, sapphire, sensors, and cooling components to ensure effective laser emission and prolong the service life of the laser.
Summary parsed at:2026-06-01 05:57:31 UTC
