DeepX DermoSight Dermatoscope— 510(k) K230448

Name: FDA 510(k) clearance K230448
Creator: U.S. Food and Drug Administration
Published: 2023-05-17

Substantially Equivalent

Deepx Health, LLC

FDA 510(k) clearance K230448 for DeepX DermoSight Dermatoscope, Substantially Equivalent on 2023-05-17. Applicant: Deepx Health, LLC. Device class: 2.

Clearance details

Applicant: Deepx Health, LLC
Product code: Code PSN
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2023-02-21
Decision date: 2023-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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