CLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES
FDA premarket approval P080004/S004 · decided 2012-04-04
Approval details
- PMA number
- P080004
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2010-01-21
- Decision date
- 2012-04-04
- Days to decision
- 804 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- APPROVAL FOR CLEAR-OPTIC SPHERIC AND ASPHERIC SURFACE INTRAOCULAR LENSES (IOLS), MODELS PC-60R, PC-60AD AND FC-60AD.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HOYA IS INJECTOR SYSTEM (K081346) | Hoya Surgical Optics, Inc. | 2009-03-23 |