TruScan Pro TP0013
TruScan Pro TP0013 is a Class II device made by Lightmed Corporation, cleared under FDA 510(k) K190448 on 24 May 2019 and listed in FDA GUDID since 8 Apr 2020 (UDI-DI 04712826770970), active as of 12 Nov 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 | Number04712826770970 | Date8 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190448 | Date24 May 2019 | StatusActive |
Official records
- AccessGUDID record 04712826770970
- FDA 510(k) database K190448
Across registries
- FDA 510(k) K190448 decided 24 May 2019 Active
- FDA GUDID UDI-DI 04712826770970 listed 8 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K190448
- Listed FDA GUDID 04712826770970
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TruScan Pro
- Generic name
- Ophthalmic solid-state laser system
- Model / reference
- TP0013
- Primary DI / UDI-DI
- 04712826770970
- 510(k) Number
- FDA product code
- HQF
- GMDN term
- Ophthalmic solid-state laser system
- Device class
- Class II
- Regulation number
- 886.4390
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ophthalmic solid-state laser system.