Manufacturer
Hebei Newangie Technology Co., Ltd.Diode laser device (BM091)
Hebei Newangie Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251801
- Device name
- Diode laser device (BM091)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-06-12
- Decision date
- 2025-08-08
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
2Diode laser therapy device
Diode Laser Hair Removal System (MBT-Diode Laser)
K251801 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251801 as a predicate
