Weifang Mingliang Electronics Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Diode Laser Therapy Systems is intended to be used for hair removal of patients with hirsutism. It is indicated for use on all skin types (Fitzpatrick Skin Types 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 Therapy Systems is intended to be used for hair removal of patients with hirsutism. It is indicated for use on all skin types (Fitzpatrick Skin Types 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 Systems hair removal is based on the principle of selective photothermal dynamics, because the skin of human body is a relatively transparent structure. The laser can penetrate the skin very smoothly and reach the hair follicle, which is the position of hair growth. The melanin in the hair follicle absorbs a lot of laser energy and finally converts it into heat energy. Make the temperature of hair follicle rise, so as to destroy the function of hair follicle, make hair lose the ability of regeneration, and then play the purpose of depilation. Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen. In the handle of the machine, the light emitted by each discharge contains 808nm wavelengths.
Summary parsed at:2026-06-01 05:19:17 UTC
