Hebei Newangie Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Diode laser 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 Diode laser 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.
Diode laser device consists of a main unit, a handheld, a foot switch and a power cord. The device includes a handle with a single-band 808nm semiconductor laser, and the semiconductor lasers of the handle are powered by the laser power supply in the host to emit the laser of the corresponding wavelength. Semiconductor laser uses semiconductor materials of different doping types as laser working substance, uses natural cleavage surface to form resonant cavity for laser oscillation and amplification, and adds forward voltage to PN junction area of semiconductor laser to form particle number inversion of non-equilibrium carrier between conduction band and valence band of semiconductor substance. When a large number of electrons and holes in particle number inversion state are recombined, excess energy will be released, and these energies will be expressed in the form of photons, that is, laser is formed. Due to resonance amplification of cleavage surface resonant cavity, stimulated feedback is realized, so that laser can be directionally emitted and output from semiconductor laser.
Summary parsed at:2026-06-01 05:23:33 UTC
