iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System
FDA premarket approval P080004/S027 · decided 2019-12-04
Approval details
- PMA number
- P080004
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2019-11-01
- Decision date
- 2019-12-04
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- Alternate supplier for applying ceramic coating to stainless steel jigs.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HOYA IS INJECTOR SYSTEM (K081346) | Hoya Surgical Optics, Inc. | 2009-03-23 |