510(k) K141091 ยท MSS Folders And Injectors, Intraocular Lens (Iol)
RAYSERT PLUS INJECTOR
| Applicant | Rayner Intraocular Lenses , Ltd., Hove, E. Sussex, GB |
| Decision | Substantially Equivalent, May 28, 2014 |
| Received | Apr 28, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2020 | Rayner Intraocular Lenses Limited RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those Open, Classified |
MSS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.