Cleared Traditional

Vista Ophthalmics Vitrectomy Probe

K220030 · Vista Ophthalmics, LLC · Ophthalmic
May 2022
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K220030 is an FDA 510(k) clearance for the Vista Ophthalmics Vitrectomy Probe, 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 review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K220030 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MLZ — Vitrectomy, Instrument Cutter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150