iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure Preloaded IOL System / Model B1PC (Clear
FDA premarket approval P080004/S047 · decided 2023-10-25
Approval details
- PMA number
- P080004
- Supplement
- S047
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2023-08-29
- Decision date
- 2023-10-25
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- Approval for a button manufacturing site located at HOYA Lamphun Ltd., 75/2 Moo 4, Tambol Banklang, Amphur, Muang, Lamphun, 51000, 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 |