PSNClass II
Light Based Imaging
General, Plastic Surgery · 21 CFR 878.4580
Emission and collection of light to create an image for medical purposes
MDR events0All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances10All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
10 clearances for this product code
- Deepx Health, LLCMay 17, 2023
K230448 · DeepX DermoSight Dermatoscope
- Barco N.V.Mar 11, 2022
K213957 · Demetra Dermatoscope BDEM-01
- Barco N.V.Feb 18, 2021
K201408 · Demetra Analytics Toolkit
- Barco N.V.Dec 13, 2019
K192829 · Demetra BDEM-01 Dermatoscope
- Caliber Imaging & Diagnostics, Inc.May 3, 2018
K180162 · VivaScope System
- Lucid, Inc.Sep 17, 2008
K080788 · VIVASCOPE SYSTEM, MODEL 1500, 3000
- Astron Clinica LimitedSep 14, 2007
K062736 · SIASCOPE V
- Visiomed AGJun 8, 2004
K040171 · MICRODERM, MODEL/VERSION 3.5