iSert Preloaded System
FDA premarket approval P080004/S031 · decided 2021-05-21
Approval details
- PMA number
- P080004
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- iSert Preloaded System
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2020-01-30
- Decision date
- 2021-05-21
- Days to decision
- 477 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. HOYA Lamphun Ltd. processes will be limited to machining, polishing, inspecting, assembly, and primary packaging (pre-sterilization) 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 |