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

Vitrectomy, Instrument Cutter

21 CFR 886.4150 / Ophthalmic
FDA source (opens on fda.gov)

MLZ is the FDA product code for Vitrectomy, Instrument Cutter, a class II device type, regulated under 21 CFR 886.4150. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
MLZ
Device name
Vitrectomy, Instrument Cutter
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
4

Clearances, product code MLZ

By decision year
4 clearances under product code MLZ with a decision year between 2008 and 2022, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MLZ by decision year
YearClearances
20081
20101
20171
20221

Applicants with the most clearances

Product code MLZ
Applicants holding the most 510(k) clearances under product code MLZ
ApplicantClearances
Alcon Laboratories2
Advanced Medical Optics, Inc.1
Vista Ophthalmics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order