iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses
FDA premarket approval P080004/S037 · decided 2020-10-13
Approval details
- PMA number
- P080004
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2020-09-14
- Decision date
- 2020-10-13
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- Manufacturing process change to the buttons used for Hoya's AF-1 family of intraocular lenses.
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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 |