IPure Preloaded IOL System
FDA premarket approval P080004/S028 · decided 2020-04-23
Approval details
- PMA number
- P080004
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IPure Preloaded IOL System
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2019-12-02
- Decision date
- 2020-04-23
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- Approval for packaging changes for the iSert® Preloaded System Platform Models 230 and 231. The device, as modified, will be marketed under the trade name IPure Preloaded IOL System Model B3PC and B3PY.
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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 |