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., Caliber Imaging & Diagnostics, Inc. and Deepx Health, LLC.
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
Cleared
May 17, 2023
DeepX DermoSight Dermatoscope
Deepx Health, LLC
General & Plastic Surgery
85d
Cleared
Mar 11, 2022
Demetra Dermatoscope BDEM-01
Barco N.V.
General & Plastic Surgery
84d
Cleared
Feb 18, 2021
Demetra Analytics Toolkit
Barco N.V.
General & Plastic Surgery
266d
Cleared
Dec 13, 2019
Demetra BDEM-01 Dermatoscope
Barco N.V.
General & Plastic Surgery
72d
Cleared
May 03, 2018
VivaScope System
Caliber Imaging & Diagnostics, Inc.
General & Plastic Surgery
104d
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.