Staar Sugical: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Staar Sugical” (first 1994, latest 1994), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 222 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 |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (1)
Most recent Staar Sugical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940593 | DISPOSABLE MICROSTAAR INJECTOR | KYB | 1994-09-19 | 222 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960033 | PMA | STAARVISC TM SODIUM HYALURONATE | 1999-07-02 |
Recalls
openFDA lists no recalls under a recalling firm named Staar Sugical.
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.
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. (24 510(k)s)
- Staar Japan (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Staar Sugical?
FDA lists 1 510(k) clearance under the applicant name “Staar Sugical” (first 1994, latest 1994), plus 1 PMA decision, across 2 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 Sugical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Staar Sugical is 222 days.
Which FDA product codes appear under Staar Sugical?
The most frequent FDA product codes under this applicant name are KYB (Lens, Guide, Intraocular, 1).
Next steps
- See all 1 Staar Sugical clearances with predicates and recalls
- Run predicate analysis for product code KYB, Staar Sugical'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.