Vista Ophthalmics Vitrectomy Probe— 510(k) K220030

Name: FDA 510(k) clearance K220030
Creator: U.S. Food and Drug Administration
Published: 2022-05-04

Substantially Equivalent

Vista Ophthalmics, LLC

FDA 510(k) clearance K220030 for Vista Ophthalmics Vitrectomy Probe, Substantially Equivalent on 2022-05-04. Applicant: Vista Ophthalmics, LLC. Device class: 2.

Clearance details

Applicant: Vista Ophthalmics, LLC
Product code: Code MLZ
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 2022-01-05
Decision date: 2022-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Katy, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLZ

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Adverse events under product code MLZ

product code MLZ

Malfunction: 692
Total: 692

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.