HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
FDA premarket approval P080004 · decided 2008-09-26
Approval details
- PMA number
- P080004
- Trade name
- HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2008-01-31
- Decision date
- 2008-09-26
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- APPROVAL FOR THE HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS. THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
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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 |