MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES
FDA premarket approval P880072/S018 · decided 1991-06-04
Approval details
- PMA number
- P880072
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES
- Generic name
- intraocular lens
- Applicant
- Eyekon Medical, Inc.
- Date received
- 1990-10-11
- Decision date
- 1991-06-04
- Days to decision
- 236 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Clearwater, FL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Temporary Keratoprosthesis (QuickSet TKP™) (K261312) | Eyekon Medical, Inc. | 2026-07-24 |