Acuity PB600-Uv-15.0
Acuity PB600-Uv-15.0 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 M454PB600UVP1501), 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 | NumberM454PB600UVP1501 | 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 M454PB600UVP1501 listed 18 Sep 2015 Listed
Timeline
- Approved FDA PMA P880072
- Listed FDA GUDID M454PB600UVP1501
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- Withdrawn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
- PB600-UV-15.0
- Primary DI / UDI-DI
- M454PB600UVP1501
- 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
Similar devices
Other devices filed under FDA product code HQL (Intraocular Lens).
- Clareon CCWTT0 by Alcon Laboratories, Inc.
- AcrySof Toric Aspheric UV Absorbing IOL SA6AT5 SA6AT5.280 by Alcon Laboratories, Inc.
- UV-Absorbing Posterior Chamber Intraocular Lenses by Aaren Scientific
- CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC by Bausch & Lomb, Inc.
- Posterior Chamber Intraocular Lenses Model SP38UB by Bausch & Lomb, Inc.
- Elastimide IOL Model AQ-2010 by Staar Surgical Co.
- Xact Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens (IOL) by Bausch & Lomb Incorporated