Manufacturer
Beijing Lead Beauty S & T Co., Ltd.Diode Laser Hair Removal Machine
Beijing Lead Beauty S & T 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
- K192735
- Device name
- Diode Laser Hair Removal Machine
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-09-27
- Decision date
- 2020-04-03
- 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 Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), 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 Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), 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 Hair Removal Machine, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch. The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body.
Summary parsed at:2026-06-01 05:47:00 UTC
Predicate devices
1Diode laser hair removal device
K192735 references 1 predicate/reference device
Cited as predicate
1Diode laser hair removal machine (QDTM-02)
1 submission cite K192735 as a predicate
