AF-1 Family of Intraocular Lens (IOL)
FDA premarket approval P080004/S033 · decided 2021-02-26
Approval details
- PMA number
- P080004
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AF-1 Family of Intraocular Lens (IOL)
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2020-03-18
- Decision date
- 2021-02-26
- Days to decision
- 345 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- approval for a new Ethylene Oxide Contract Sterilizer, SIAM STERI SERVICES CO. LTD., Phan Thong, Chon Buri, 20160 Thailand
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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 |