K202038 is an FDA 510(k) clearance for the CryoTreQ. This device is classified as a Unit, Cryophthalmic (Class II - Special Controls, product code HPS).
Submitted by Vitreq BV (Vierpolders, NL). The FDA issued a Cleared decision on December 30, 2020, 160 days after receiving the submission on July 23, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4170.
| 510(k) Number | K202038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2020 |
| Decision Date | December 30, 2020 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPS - Unit, Cryophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4170 |