Rayner Intraocular Lenses , Ltd.: FDA clearances and approvals
Rayner Intraocular Lenses , Ltd. has 4 FDA 510(k) clearances (first 2009, latest 2014), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time: 114 days. openFDA lists 1 product recall by a recalling firm named Rayner Intraocular Lenses , Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 3 | 30 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 4 | 4 |
| HQL | Intraocular Lens | 1 | 0 |
Review panels
- Ophthalmic (5)
Most recent Rayner Intraocular Lenses , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector | MSS | 2014-12-18 | 30 |
| K141091 | RAYSERT PLUS INJECTOR | MSS | 2014-05-28 | 30 |
| K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR | MSS | 2014-03-27 | 269 |
| K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 | MSS | 2009-12-04 | 197 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P060011 | PMA | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) | 2007-05-03 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-05-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Rayner Intraocular Lenses , Ltd. have?
Rayner Intraocular Lenses , Ltd. has 4 FDA 510(k) clearances (first 2009, latest 2014), plus 1 PMA decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Rayner Intraocular Lenses , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Rayner Intraocular Lenses , Ltd.'s cleared 510(k)s is 114 days.
What devices does Rayner Intraocular Lenses , Ltd. make?
Its most frequent FDA product codes are MSS (Folders And Injectors, Intraocular Lens (Iol), 4); HQL (Intraocular Lens, 1).
Has Rayner Intraocular Lenses , Ltd. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Rayner Intraocular Lenses , Ltd; the most recent began 2022-05-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 4 Rayner Intraocular Lenses , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MSS, Rayner Intraocular Lenses , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.