Cleared Special

Demetra Dermatoscope BDEM-01

K213957 · Barco N.V. · General & Plastic Surgery
Mar 2022
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K213957 is an FDA 510(k) clearance for the Demetra Dermatoscope BDEM-01, a Light Based Imaging (Class II — Special Controls, product code PSN), submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on March 11, 2022, 84 days after receiving the submission on December 17, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K213957 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PSN — Light Based Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580
Definition Emission And Collection Of Light To Create An Image For Medical Purposes