Cleared Special

K213957 - Demetra Dermatoscope BDEM-01

K213957 is an FDA 510(k) clearance for Demetra Dermatoscope BDEM-01, manufactured by Barco N.V.. The device is a Class 2 General & Plastic Surgery device with product code PSN cleared through the Special 510(k) pathway after a 84-day FDA review.

K213957 · Barco N.V. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
84d
Days
Class 2
Risk

K213957 is an FDA 510(k) clearance for the Demetra Dermatoscope BDEM-01. Classified as Light Based Imaging (product code PSN), Class II - Special Controls.

Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on March 11, 2022 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K213957

510(k) Number K213957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2021
Decision Date March 11, 2022
Days to Decision 84 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

PSN Device Classification - Class 2, Special Controls

Product Code PSN Light Based Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
Definition Emission And Collection Of Light To Create An Image For Medical Purposes
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PSN Light Based Imaging

All 9
Devices cleared under the same product code (PSN) and FDA review panel - the closest regulatory comparables to K213957.
DeepX DermoSight Dermatoscope
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Demetra Analytics Toolkit
K201408 · Barco N.V. · Feb 2021
Demetra BDEM-01 Dermatoscope
K192829 · Barco N.V. · Dec 2019
VivaScope System
K180162 · Caliber Imaging & Diagnostics, Inc. · May 2018
VIVASCOPE SYSTEM, MODEL 1500, 3000
K080788 · Lucid, Inc. · Sep 2008
SIASCOPE V
K062736 · Astron Clinica Limited · Sep 2007
K213957 · Demetra Dermatoscope BDEM-01
Download PDF FDA Summary Barco N.V.