Beijing Adss Development Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Diode Laser Therapy Machine 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 Machine 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 Therapy Machine, is a surgical device intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). There are 4 models included: FG 2000, FG 2000-B, FG 2000-C, and FG 2000-D, which have the same intended use, mechanism of action, principle, and specification, with differences in configuration. The system provides 36 working modes, including six modes for men and six modes for women, with adjustable parameters for each mode. The treatment can be applied on different Fitzpatrick skin types, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown), and VI (Black).
Summary parsed at:2026-06-01 06:06:38 UTC
