Corneagen, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Corneagen, Inc.” (first 2022, latest 2022), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 421 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 |
|---|---|---|
| 2022 | 1 | 421 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Corneagen, Inc. took a median 421 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 421 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LQE | Implant, Corneal, Refractive | 1 | 0 |
| OTZ | Graft Insertion Instrument For Endothelial Keratoplasty | 1 | 1 |
Review panels
- Ophthalmic (2)
Most recent Corneagen, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203586 | EndoSerter-PL | OTZ | 2022-02-02 | 421 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P120023 | PMA | KAMRA INLAY | 2015-04-17 |
Recalls
openFDA lists no recalls under a recalling firm named Corneagen, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Corneagen, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Corneagen, Inc.” (first 2022, latest 2022), 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 Corneagen, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corneagen, Inc. is 421 days.
Which FDA product codes appear under Corneagen, Inc.?
The most frequent FDA product codes under this applicant name are LQE (Implant, Corneal, Refractive, 1); OTZ (Graft Insertion Instrument For Endothelial Keratoplasty, 1).
Next steps
- See all 1 Corneagen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LQE, Corneagen, Inc.'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.