Beijing Globalipl Development Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The US 450 Diode Laser Equipment 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 US 450 Diode Laser Equipment 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.
US450 Diode Laser Equipment is a device which adopts the high‐energy and continuous diode laser to realize the conversion of electricity, light and heat energy, and thus achieves disease treatment. Therefore, this is a laser therapeutic product that integrates laser technology, electronic technology, computer science and medical science. Under the control of microprocessor, laser power supply can provide the adjustable constant current for the laser module, the high power laser diode in the laser module can transform the electric energy into the light, generate the continuous laser beam with a wavelength of 808nm. Semiconductor laser used for hair removal is mainly based on the principle of selective photothermal action, that is, a specific wavelength of laser can only be selectively absorbed by the target color base. US450 Diode Laser Equipment consists of power supply system, microprocessor control system, operation display system, cooling system, treatment handle and safety alarm system.
Summary parsed at:2026-06-01 05:40:35 UTC
