Superlaser Sl-HR10
by Beijing Superlaser Technology Co., Ltd.
Superlaser Sl-HR10 is a dermatological diode laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Beijing Superlaser Technology Co., Ltd., cleared under FDA 510(k) K192516 on 10 Dec 2019 and listed in FDA GUDID since 8 Aug 2020 (UDI-DI 06973537441001), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06973537441001 | Date8 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192516 | Date10 Dec 2019 | StatusActive |
Official records
- AccessGUDID record 06973537441001
- FDA 510(k) database K192516
Across registries
- FDA 510(k) K192516 decided 10 Dec 2019 Active
- FDA GUDID UDI-DI 06973537441001 listed 8 Aug 2020 Listed
Timeline
- Cleared FDA 510(k) K192516
- Listed FDA GUDID 06973537441001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Superlaser
- Generic name
- Dermatological diode laser system
- Model / reference
- SL-HR10
- Primary DI / UDI-DI
- 06973537441001
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological diode laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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