600C ASPHERIC INTRAOCULAR LENS
FDA premarket approval P060011/S005 · decided 2015-05-01
Approval details
- PMA number
- P060011
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 600C ASPHERIC INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Rayner Intraocular Lenses , Ltd.
- Date received
- 2015-02-02
- Decision date
- 2015-05-01
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Hove, E. Sussex
- Statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS OF THE C-FLEX ASPHERIC IOL MODEL 970C: 1) INCREASE OF OVERALL DIAMETER FROM 12.00 MM TO 12.50 MM; 2) INCREASE OF OPTIC SIZE FROM 5.75 MM TO 6.00 MM; AND 3) AN EXTENSION OF THE HIGH POWERED DIOPTRIC RANGE FROM +30.0D TO +34.0D. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 600C ASPHERIC INTRAOCULAR LENS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PH
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (K143307) | Rayner Intraocular Lenses , Ltd. | 2014-12-18 |
| RAYSERT PLUS INJECTOR (K141091) | Rayner Intraocular Lenses , Ltd. | 2014-05-28 |
| 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 |