RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES
FDA premarket approval P060011/S003 · decided 2012-03-08
Approval details
- PMA number
- P060011
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Rayner Intraocular Lenses , Ltd.
- Date received
- 2012-02-06
- Decision date
- 2012-03-08
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Hove, E. Sussex
- Statement
- SOFTWARE UPGRADE TO THE OPTICAL MEASURING EQUIPMENT.
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510(k) clearances by this applicant
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|---|---|---|
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| SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR (K132002) | Rayner Intraocular Lenses , Ltd. | 2014-03-27 |
| RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 (K091507) | Rayner Intraocular Lenses , Ltd. | 2009-12-04 |