Manufacturer
Beijing Superlaser Technology Co., Ltd.Diode Laser 808nm
Beijing Superlaser 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
- K192516
- Device name
- Diode Laser 808nm
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-09-13
- Decision date
- 2019-12-10
- 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 808nm 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 808nm 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 Diode Laser 808nm is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. The proposed device has six main function modules: 1. Water cooling system: Achieves heat and cold exchange of air through a refrigeration compressor and a water pump for cooling water cycle. 2. Power system: Provides the size of laser energy according to control requirements. 3. User Interface system: Displays relevant information and allows users to set parameters or functions. 4. Handpiece system: Allows selection of appropriate treatment tools based on treatment methods. 5. Main circuit power supply system: Supplies power to the equipment and controls the power supply. 6. Main circuit control system: Controls the operation sequence of equipment parts and provides fault or warning sounds.
Summary parsed at:2026-06-01 05:55:54 UTC
Predicate devices
2Diode laser hair removal device
Diode Laser System
K192516 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 K192516 as a predicate
