RayOne EMV Toric
FDA premarket approval P060011/S039 · decided 2025-10-09
Approval details
- PMA number
- P060011
- Supplement
- S039
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RayOne EMV Toric
- Generic name
- intraocular lens
- Applicant
- Rayner Intraocular Lenses , Ltd.
- Date received
- 2025-03-17
- Decision date
- 2025-10-09
- Days to decision
- 206 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Hove, E. Sussex
- Statement
- premarket approval application (PMA) supplement for the RayOne EMV Toric (Model RAO210T) consists of the EMV Toric IOL (210T) preloaded within the RayOne injection system (RAO). The EMV Toric IOL is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia, in adult patients in whom a cataractous lens has been removed by phacoemulsification and providing reduction of residual refractive astigmatism in adult patients with greater than or equal to 1.00 d
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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 |