510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220030Substantially Equivalent

Vista Ophthalmics Vitrectomy Probe

Vista Ophthalmics, Katy TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220030 is the FDA 510(k) clearance record for Vista Ophthalmics Vitrectomy Probe, a class II device, cleared for Vista Ophthalmics, LLC on under FDA product code MLZ (Vitrectomy, Instrument Cutter). FDA records list one 510(k) clearance for Vista Ophthalmics, LLC. As of , FDA records show no recalls naming K220030.

Clearance record

Decision date
Received
(119 days to decision)
Product code
MLZ Vitrectomy, Instrument Cutter
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Applicant
Vista Ophthalmics, LLC 23510 Kingsland Blvd. Suite 200, Katy TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MLZ

Trailing 12 months

FDA records hold no clearances under product code MLZ in the trailing twelve months.

FDA records show no clearances under product code MLZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MLZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260