iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231 & IPure Preloaded IOL System/ Model B1PC (Clear
FDA premarket approval P080004/S046 · decided 2023-05-04
Approval details
- PMA number
- P080004
- Supplement
- S046
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231 & IPure Preloaded IOL System/ Model B1PC (Clear
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2022-12-02
- Decision date
- 2023-05-04
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- Approval for a reduction in the duration of the heated aeration phase of your existing approved Ethylene Oxide sterilization process.
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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 |