Enhanced AURORA Medical Diode System, and related accessories— 510(k) K230076

Name: FDA 510(k) clearance K230076
Creator: U.S. Food and Drug Administration
Published: 2023-03-08

Substantially Equivalent

Psoria-Shield, Inc.

FDA 510(k) clearance K230076 for Enhanced AURORA Medical Diode System, and related accessories, Substantially Equivalent on 2023-03-08. Applicant: Psoria-Shield, Inc.. Device class: 2.

Clearance details

Applicant: Psoria-Shield, Inc.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2023-01-10
Decision date: 2023-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

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