K220030 is an FDA 510(k) clearance for the Vista Ophthalmics Vitrectomy Probe. This device is classified as a Vitrectomy, Instrument Cutter (Class II - Special Controls, product code MLZ).
Submitted by Vista Ophthalmics, LLC (Katy, US). The FDA issued a Cleared decision on May 4, 2022, 119 days after receiving the submission on January 5, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K220030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2022 |
| Decision Date | May 04, 2022 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MLZ - Vitrectomy, Instrument Cutter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |