PSN · Class II · 21 CFR 878.4580

FDA Product Code PSN: Light Based Imaging

Emission And Collection Of Light To Create An Image For Medical Purposes

Leading manufacturers include Barco N.V..

10
Total
10
Cleared
168d
Avg days
2002
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Light Based Imaging Devices (Product Code PSN)

10 devices
1–10 of 10
Cleared Mar 11, 2022
Demetra Dermatoscope BDEM-01
K213957
Barco N.V.
General & Plastic Surgery · 84d
Cleared Feb 18, 2021
Demetra Analytics Toolkit
K201408
Barco N.V.
General & Plastic Surgery · 266d

About Product Code PSN - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code PSN since 2002, with 10 receiving FDA clearance (average review time: 168 days).

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

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