510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081681Substantially Equivalent

Vitrectomy Cutter and Accessories

Advanced Medical Optics, Inc., Santa Ana CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081681 is the FDA 510(k) clearance record for VITRECTOMY CUTTER AND ACCESSORIES, a class II device, cleared for Advanced Medical Optics, Inc. on under FDA product code MLZ (Vitrectomy, Instrument Cutter). FDA records list 38 510(k) clearances for Advanced Medical Optics, Inc., from to . As of , FDA records show 2 recalls naming K081681.

Clearance record

Decision date
Received
(113 days to decision)
Product code
MLZ Vitrectomy, Instrument Cutter
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Applicant
Advanced Medical Optics, Inc. 1700 E. St. Andrew Pl., Santa Ana CA
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