Manufacturer
Zhengzhou Bestview ST Co., Ltd.Diode Laser Machine, Model Number: BM-100
Zhengzhou Bestview ST Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K211335
- Device name
- Diode Laser Machine, Model Number: BM-100
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-05-03
- Decision date
- 2021-07-28
- 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 Hair Removal System 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 Hair Removal System 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
The proposed device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. Main components of the device include the laser console, liquid crystal display (LCD) touchscreen control panel, and laser handpiece. The device emits pulses of the 808 nm infrared laser emissions at pulse widths, repetition frequency, and energy levels, conductive to hair removal. The device incorporates water cooling, air cooling fan, and switches/buttons to control the laser output. The device is powered via an alternating current power source.
Summary parsed at:2026-06-01 05:42:59 UTC
Predicate devices
2Diode Laser Hair Removal System
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Not ingested
K211335 references 2 predicate/reference devices
Cited as predicate
4Diode Laser Hair Removal System (RD-SLD600)
Diode Laser Therapy Device (DF-DIODE LASER-S1)
Diode Laser Hair Removal System (MBT-Diode Laser)
Diode Laser Hair Removal Machine (GLD01)
4 submissions cite K211335 as a predicate
