iSert Preloaded IOL System, IPure Preloaded IOL System
FDA premarket approval P080004/S045 · decided 2023-06-22
Approval details
- PMA number
- P080004
- Supplement
- S045
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- iSert Preloaded IOL System, IPure Preloaded IOL System
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2022-07-21
- Decision date
- 2023-06-22
- Days to decision
- 336 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- Approval for a manufacturing site located at HOYA Lamphun Ltd., 725 Moo 4, Tambol Banklang, Amphur Muagn, Lamphun 5100, Thailand. Manufacturing processes will be limited to lathe cutting through primary packaging, shipment to and from sterilizer, Siam Steri Service Co. LTD, secondary packaging, and distribution of intraocular lenses (IOLs) and injector cartridges.
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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 |