MLZ · Class II · 21 CFR 886.4150

FDA Product Code MLZ: Vitrectomy, Instrument Cutter

Leading manufacturers include Alcon Research, Ltd., Advanced Medical Optics, Inc. and Vista Ophthalmics, LLC.

4
Total
4
Cleared
106d
Avg days
2008
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Vitrectomy, Instrument Cutter Devices (Product Code MLZ)

4 devices
1–4 of 4
Cleared May 04, 2022
Vista Ophthalmics Vitrectomy Probe
K220030
Vista Ophthalmics, LLC
Ophthalmic · 119d
Cleared Mar 22, 2017
HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
K170520
Alcon Research, Ltd.
Ophthalmic · 28d
Cleared Apr 02, 2010
ENHANCED ULTRA VIT PROBE
K093305
Alcon Research, Ltd.
Ophthalmic · 162d
Cleared Oct 08, 2008
VITRECTOMY CUTTER AND ACCESSORIES
K081681
Advanced Medical Optics, Inc.
Ophthalmic · 113d

About Product Code MLZ - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code MLZ since 2008, with 4 receiving FDA clearance (average review time: 106 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.