SureLase 4060
SureLase 4060 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Clinicon Corp., cleared under FDA 510(k) K121580 on 25 Sep 2012 and listed in FDA GUDID since 5 May 2021 (UDI-DI 00850013050215), active as of 23 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 | Number00850013050215 | Date5 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121580 | Date25 Sep 2012 | StatusActive |
Official records
- AccessGUDID record 00850013050215
- FDA 510(k) database K121580
Across registries
- FDA 510(k) K121580 decided 25 Sep 2012 Active
- FDA GUDID UDI-DI 00850013050215 listed 5 May 2021 Listed
Timeline
- Cleared FDA 510(k) K121580
- Listed FDA GUDID 00850013050215
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SureLase
- Generic name
- General/multiple surgical diode/carbon dioxide laser system
- Model / reference
- 4060
- Primary DI / UDI-DI
- 00850013050215
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical diode/carbon dioxide laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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