STAAR Surgical Company: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “STAAR Surgical Company” (first 2015, latest 2017), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 71 |
| 2016 | 0 | — |
| 2017 | 1 | 30 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name STAAR Surgical Company took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | 1 | 1 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 | 1 |
| MTA | Lens, Intraocular, Phakic | 1 | 0 |
Review panels
- Ophthalmic (3)
Most recent STAAR Surgical Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172375 | MicroSTAAR Injector System Cartridges | MSS | 2017-09-06 | 30 |
| K152357 | MicroSTAAR Injector System Cartridges | KYB | 2015-10-30 | 71 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030016 | PMA | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | 2005-12-22 |
Recalls
11 product recalls in 1 recall events; 11 initiated in the last five years. Most recent: 2023-09-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named STAAR Surgical Company is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05538754: Post-Market Evaluation of the EVO ICL (Completed, started 2022-09-23)
- NCT07291739: A Clinical Evaluation of a Phakic Intraocular Lens (Completed, started 2022-08-22)
- NCT04516772: STAAR Visian Toric ICL Post-Approval Study (Completed, started 2020-07-21)
- NCT04283149: Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL) (Completed, started 2020-01-30)
- NCT03499821: Clinical Performance of a Phakic Intraocular Lens (IOL) (Completed, started 2018-03-20)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Staar Surgical Co. (22 510(k)s)
- Staar Sugical (1 510(k)s)
- Staar Japan (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under STAAR Surgical Company?
FDA lists 2 510(k) clearances under the applicant name “STAAR Surgical Company” (first 2015, latest 2017), plus 1 PMA decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by STAAR Surgical Company?
The median time from FDA receipt to decision across 510(k)s cleared under the name STAAR Surgical Company is 50 days.
Which FDA product codes appear under STAAR Surgical Company?
The most frequent FDA product codes under this applicant name are KYB (Lens, Guide, Intraocular, 1); MSS (Folders And Injectors, Intraocular Lens (Iol), 1); MTA (Lens, Intraocular, Phakic, 1).
Next steps
- See all 2 STAAR Surgical Company clearances with predicates and recalls
- Run predicate analysis for product code KYB, STAAR Surgical Company's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.