San HE Lefis Electronics Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Diode Laser Therapy 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 Therapy 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, is a surgical device intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). The power system includes a network power supply, laser power supply system, refrigeration power supply system, and auxiliary power supply system. The power lines and rocker switch control the on-off of the hair removal instrument with the outside power supply. The key switch and emergency stop switch control the on-off of network power, providing work current for the microprocessor control system, touch screen operation display system, and other functional components. The power system has a self-protection function, notifying users through the touch screen interface in case of errors. The microprocessor control system automates the operation, performing self-checks and calling treatment parameters. The operation display system consists of a touch screen, indicator, and buzzer, allowing the operator to control the microprocessor and monitor the device state and parameters.
Summary parsed at:2026-06-01 05:56:01 UTC
