Shanghai Omni Laser Skinology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Diode Laser Hair Removal System (RD-SLD600) 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.
Diode Laser Hair Removal System (RD-SLD600) 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 (RD-SLD600) is a professional platform, it is intended for the removal of unwanted hair and to effect stable, long-term hair reduction on all skin types (Fitzpatrick skin type I-VI). The complete system consists of its console, module and a footswitch. The module is pressed against the patient's skin and a light pulse is delivered when the emitted button or the footswitch are activated. The crystal contact surface is cooled by the RD-SLD600's cooling system. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system's microcontroller through and LCD touch-screen.
Summary parsed at:2026-06-01 05:32:24 UTC
