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510(k) K230448

DeepX DermoSight Dermatoscope by Deepx Health, LLC — Product Code PSN

K230448 is an FDA 510(k) premarket notification submitted by Deepx Health, LLC for the device "DeepX DermoSight Dermatoscope". The FDA issued a decision of Substantially Equivalent on May 17, 2023. The device falls under product code PSN (Light Based Imaging), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2023
Date Received
February 21, 2023
Clearance Type
Traditional
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

Other clearances for product code PSN

  • K213957 — Demetra Dermatoscope BDEM-01 (March 11, 2022)
  • K201408 — Demetra Analytics Toolkit (February 18, 2021)
  • K192829 — Demetra BDEM-01 Dermatoscope (December 13, 2019)
  • 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)

FDA data resources