QZN · Class II · 21 CFR 878.4580

FDA Product Code QZN: Multi-photon Imaging

To Provide Visible Illumination Of The Surgical Field Or The Patient

Leading manufacturers include Enspectra Health, Inc..

1
Total
1
Cleared
102d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Multi-photon Imaging Devices (Product Code QZN)

1 devices
1–1 of 1
Cleared Dec 22, 2023
VIO System (V-1000)
K232789
Enspectra Health, Inc.
General & Plastic Surgery · 102d

About Product Code QZN - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QZN since 2023, with 1 receiving FDA clearance (average review time: 102 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QZN devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →