Shenzhen Leaflife Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Laser Therapy Device 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 Laser Therapy Device 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 Laser Therapy Device is a surgical device intended for use in dermatologic and general surgical procedures. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser hand piece. The emission laser is activated by a foot switch and a hand piece. The components of the Laser Therapy Device mainly include the main unit, hand piece, water cup, overflow tube, foot switch, key, interlock, power cord, fuse, glasses, and blindfold. The proposed Laser Therapy Device is equipped with a laser depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The laser can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs laser energy, the temperature rises, damaging the surrounding hair follicle tissues and removing the hairs.
Summary parsed at:2026-06-01 05:48:44 UTC
