Smileyscope System (Therapy Mode)— 510(k) K230825

Name: FDA 510(k) clearance K230825
Creator: U.S. Food and Drug Administration
Published: 2023-09-25

Substantially Equivalent

Smileyscope Holding, Inc.

FDA 510(k) clearance K230825 for Smileyscope System (Therapy Mode), Substantially Equivalent on 2023-09-25. Applicant: Smileyscope Holding, Inc.. Device class: 2.

Clearance details

Applicant: Smileyscope Holding, Inc.
Product code: Code QRA
Device class: Class 2
Regulation: 21 CFR 890.5800
Advisory panel: Neurology
Date received: 2023-03-24
Decision date: 2023-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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