MLZ · Class II · 21 CFR 886.4150

FDA Product Code MLZ: Vitrectomy, Instrument Cutter

Leading manufacturers include 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

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.

MLZ devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →