K213957 is an FDA 510(k) clearance for the Demetra Dermatoscope BDEM-01. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4580. Emission And Collection Of Light To Create An Image For Medical Purposes.
| 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 |
| 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 |