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 Astron Clinica Limited, Barco N.V. and Visiomed AG.

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 May 17, 2023
DeepX DermoSight Dermatoscope
K230448
Deepx Health, LLC
General & Plastic Surgery · 85d
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
Cleared Dec 13, 2019
Demetra BDEM-01 Dermatoscope
K192829
Barco N.V.
General & Plastic Surgery · 72d
Cleared May 03, 2018
VivaScope System
K180162
Caliber Imaging & Diagnostics, Inc.
General & Plastic Surgery · 104d
Cleared Sep 17, 2008
VIVASCOPE SYSTEM, MODEL 1500, 3000
K080788
Lucid, Inc.
General & Plastic Surgery · 181d
Cleared Sep 14, 2007
SIASCOPE V
K062736
Astron Clinica Limited
General & Plastic Surgery · 366d
Cleared Jun 08, 2004
MICRODERM, MODEL/VERSION 3.5
K040171
Visiomed AG
General & Plastic Surgery · 134d
Cleared Feb 03, 2003
SIASCOPE II
K023729
Astron Clinica Limited
General & Plastic Surgery · 89d
Cleared Feb 20, 2002
SI ASCOPE
K011273
Astron Clinica Limited
General & Plastic Surgery · 300d

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.