Manufacturer
Beijing Adss Development Co., Ltd.Diode Laser Therapy Machine
Beijing Adss Development 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
- K161692
- Device name
- Diode Laser Therapy Machine
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-06-20
- Decision date
- 2016-11-16
- 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 Therapy Machine 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 Therapy Machine 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, Diode Laser Therapy Machine, is a surgical device intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). There are 4 models included: FG 2000, FG 2000-B, FG 2000-C, and FG 2000-D, which have the same intended use, mechanism of action, principle, and specification, with differences in configuration. The system provides 36 working modes, including six modes for men and six modes for women, with adjustable parameters for each mode. The treatment can be applied on different Fitzpatrick skin types, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown), and VI (Black).
Summary parsed at:2026-06-01 06:06:38 UTC
Predicate devices
2Cited as predicate
4New Era
Diode Laser Treatment System
Diode Laser Hair Removal System
Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
4 submissions cite K161692 as a predicate
