Beijing Unt Technology 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 therapy system, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handle. The emission laser is activated by handle and footswitch linkage. The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black).
Summary parsed at:2026-06-01 05:43:57 UTC
