RayOne EMV
FDA premarket approval P060011/S037 · decided 2025-02-05
Approval details
- PMA number
- P060011
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RayOne EMV
- Generic name
- intraocular lens
- Applicant
- Rayner Intraocular Lenses , Ltd.
- Date received
- 2024-05-03
- Decision date
- 2025-02-05
- Days to decision
- 278 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Hove, E. Sussex
- Statement
- approval for moving the manufacturing site location responsible for the coating process for RayOne injector components and approval for increasing the shelf life from 2 years to 5 years (stored at 35°C)
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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 |