The following data is part of a premarket notification filed by Vista Ophthalmics Llc with the FDA for Vista Ophthalmics Vitrectomy Probe.
| Device ID | K220030 |
| 510k Number | K220030 |
| Device Name: | Vista Ophthalmics Vitrectomy Probe |
| Classification | Vitrectomy, Instrument Cutter |
| Applicant | Vista Ophthalmics LLC 23510 Kingsland Blvd. Suite 200 Katy, TX 77494 |
| Contact | Don Knowles |
| Correspondent | Debe Deck Regulatory Pathways Group Inc. 340 S. Lemon Ave, #2471 Walnut, CA 91789 |
| Product Code | MLZ |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-05-04 |