ISERT MODEL 251 PRELOADED POSTERIOR CHAMBER IOL LEVEL B MODIFICATION OF PARENT IOL
FDA premarket approval P080004/S011 · decided 2013-07-10
Approval details
- PMA number
- P080004
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Trade name
- ISERT MODEL 251 PRELOADED POSTERIOR CHAMBER IOL LEVEL B MODIFICATION OF PARENT IOL
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2012-05-18
- Decision date
- 2013-07-10
- Days to decision
- 418 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- APPROVAL FOR THE ISERT® MODEL 251 PRELOADED POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) AND ISERT® MODEL 250 PRELOADED POSTERIOR CHAMBER IOL.
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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 |