K212763 is an FDA 510(k) clearance for the UniVit HE, UniVit UHS. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II - Special Controls, product code HQE).
Submitted by Visioncare Devices, LLC (Anderson, US). The FDA issued a Cleared decision on August 10, 2022, 344 days after receiving the submission on August 31, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K212763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2021 |
| Decision Date | August 10, 2022 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQE - Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |