510(k) K202038 ยท HPS Unit, Cryophthalmic
CryoTreQ
| Applicant | VitreQ BV, Vierpolders, NL |
| Decision | Substantially Equivalent, Dec 30, 2020 |
| Received | Jul 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2023 | Beaver Visitec International, Inc. CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the d Open, Classified |
HPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.