ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)
FDA premarket approval P080004/S015 · decided 2014-06-16
Approval details
- PMA number
- P080004
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2014-03-19
- Decision date
- 2014-06-16
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- APPROVAL FOR AN OPTICAL DESIGN CURVATURE MODIFICATION TO THE ISERT® MODEL 251 TO ADD A CONTROLLED POSITIVE SPHERICAL ABERRATION TO THE OPTIC. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISERT® GEMETRIC MODEL 751 AND IS INDICATEDFOR IMPLANTATION AFTER EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION OF CATARACTS IN ADULTS. THIS LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.
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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 |