DeviceClearance

Product code MLZ— Ophthalmic

ENHANCED ULTRA VIT PROBE

Classification name
Vitrectomy, Instrument Cutter
Device class
Class 2
Regulation
21 CFR 886.4150
Advisory panel
Ophthalmic
Total cleared
4
First cleared
Most recent

Market context for product code MLZ

FDA has cleared 4 devices under product code MLZ between 2008 and 2022, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MLZ

Adverse events under product code MLZ

product code MLZ
Malfunction
692
Total
692

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

Recent clearances under product code MLZ

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