SeeNA
SEENA006100 is a corneal topography system analyser (FDA Class II; FDA product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered) made by Visia Imaging SRL, cleared under FDA 510(k) K160327 on 5 Oct 2016 and listed in FDA GUDID since 26 May 2023 (UDI-DI 08034028770470), active as of 8 Jun 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 | Number08034028770470 | Date26 May 2023 | StatusListed |
| United States | FDA 510(k) | NumberK160327 | Date5 Oct 2016 | StatusActive |
Official records
- AccessGUDID record 08034028770470
- FDA 510(k) database K160327
Across registries
- FDA 510(k) K160327 decided 5 Oct 2016 Active
- FDA GUDID UDI-DI 08034028770470 listed 26 May 2023 Listed
Timeline
- Cleared FDA 510(k) K160327
- Listed FDA GUDID 08034028770470
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Corneal topography system analyser
- Model / Ref / Catalog
- SeeNA, SEENA006100
- Primary DI / UDI-DI
- 08034028770470
- 510(k) Number
- FDA product code
- HJO
- GMDN term
- Corneal topography system analyser
- Device class
- Class II
- Regulation number
- 886.1850
- GUDID distribution status
- In Commercial Distribution
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