Staar Surgical Co.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Staar Surgical Co.” (first 1983, latest 2009), plus 2 PMA decisions, across 10 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 6 | 6 |
| KYB | Lens, Guide, Intraocular | 6 | 6 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 4 | 4 |
| HQL | Intraocular Lens | 2 | 1 |
| HNR | Forceps, Ophthalmic | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| KYF | Implant, Eye Valve | 1 | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (22)
- Microbiology (1)
Most recent Staar Surgical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090161 | EPIPHANY INJECTION SYSTEM | MSS | 2009-06-09 | 138 |
| K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | MSS | 2008-03-13 | 84 |
| K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | MSS | 2008-03-13 | 84 |
| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | KYB | 2004-06-10 | 310 |
| K020734 | SURGE-FREE ASPIRATION ADAPTER | HQC | 2002-05-16 | 71 |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | KYB | 1998-12-04 | 87 |
| K980696 | FOAM TIP INJECTOR | MSS | 1998-09-11 | 200 |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | KYB | 1995-12-21 | 87 |
| K913626 | SOFTRANS INJECTOR | HQL | 1991-12-18 | 125 |
| K884241 | STAAR PHACO XL SMALL INCISION SYSTEM | HQC | 1989-02-17 | 129 |
12 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P900048 | PMA | ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM | 1991-09-17 |
| P880091 | PMA | ELASTIC UVA PC IOL. | 1991-09-16 |
Recalls
11 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2016-05-02.
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.
SEC filings
STAAR SURGICAL CO (STAA): EDGAR filings, CIK 718937. An SEC registrant with the same name, matched by name only.
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 Company (2 510(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 Co.?
FDA lists 22 510(k) clearances under the applicant name “Staar Surgical Co.” (first 1983, latest 2009), plus 2 PMA decisions, across 10 product codes in 2 review panels. 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 Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Staar Surgical Co. is 84 days.
Which FDA product codes appear under Staar Surgical Co.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 6); KYB (Lens, Guide, Intraocular, 6); MSS (Folders And Injectors, Intraocular Lens (Iol), 4).
Next steps
- See all 22 Staar Surgical Co. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Staar Surgical Co.'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.