C-FLEX ASPHERIC INTRAOCULAR LENS
FDA premarket approval P060011/S004 · decided 2012-07-17
Approval details
- PMA number
- P060011
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- C-FLEX ASPHERIC INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Rayner Intraocular Lenses , Ltd.
- Date received
- 2012-05-29
- Decision date
- 2012-07-17
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Hove, E. Sussex
- Statement
- APPROVAL FOR THE ADDITION OF AN ASPHERIC OPTICAL SURFACE TO THE ANTERIOR SURFACE OF THE PARENT C-FLEX INTRAOCULAR LENS MODEL 570C (POWER RANGE +8.0 TO + 17.5 D).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |