Acuity ON500-Uv-29.0
Acuity ON500-Uv-29.0 is a Class III device made by Eyekon Medical Inc., approved under FDA PMA P880072 on 22 Sep 1989 and listed in FDA GUDID since 18 Sep 2015 (UDI-DI M454ON500UVP2901), active as of 8 Nov 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM454ON500UVP2901 | Date18 Sep 2015 | StatusListed |
| United States | FDA PMAAPPR | NumberP880072 | Date22 Sep 1989 | StatusActive |
Official records
- FDA PMA database P880072
Across registries
- FDA PMA P880072 decided 22 Sep 1989 Active
- FDA GUDID UDI-DI M454ON500UVP2901 listed 18 Sep 2015 Listed
Timeline
- Approved FDA PMA P880072
- Listed FDA GUDID M454ON500UVP2901
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Acuity
- Generic name
- Posterior-chamber intraocular lens, pseudophakic
- Model / reference
- ON500-UV-29.0
- Primary DI / UDI-DI
- M454ON500UVP2901
- PMA number
- FDA product code
- HQL
- GMDN term
- Posterior-chamber intraocular lens, pseudophakic
- Device class
- Class III
- Regulation number
- 886.3600
- GUDID distribution status
- In Commercial Distribution
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