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510(k) K213957

Demetra Dermatoscope BDEM-01 by Barco N.V. — Product Code PSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2022
Date Received
December 17, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Imaging
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Emission and collection of light to create an image for medical purposes

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Other clearances for product code PSN

  • K230448 — DeepX DermoSight Dermatoscope (May 17, 2023)
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  • K180162 — VivaScope System (May 3, 2018)
  • K080788 — VIVASCOPE SYSTEM, MODEL 1500, 3000 (September 17, 2008)
  • K062736 — SIASCOPE V (September 14, 2007)
  • K040171 — MICRODERM, MODEL/VERSION 3.5 (June 8, 2004)
  • K023729 — SIASCOPE II (February 3, 2003)
  • K011273 — SI ASCOPE (February 20, 2002)