LightScalpel LS-20107-01
LightScalpel LS-20107-01 is a laser adaptor (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Lightscalpel Inc, cleared under FDA 510(k) K141658 on 22 Oct 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00851842007128), 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 | Number00851842007128 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141658 | Date22 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 00851842007128
- FDA 510(k) database K141658
Across registries
- FDA 510(k) K141658 decided 22 Oct 2014 Active
- FDA GUDID UDI-DI 00851842007128 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K141658
- Listed FDA GUDID 00851842007128
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LightScalpel
- Generic name
- Laser adaptor
- Model / Ref / Catalog
- LS-20107-01, 20107-01
- Primary DI / UDI-DI
- 00851842007128
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Laser adaptor
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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