StarFormer (M008-3T)— 510(k) K241785

Substantially Equivalent

Fotona D.O.O.

FDA 510(k) clearance K241785 for StarFormer (M008-3T), Substantially Equivalent on 2025-03-27. Applicant: Fotona D.O.O.. Device class: 2.

Clearance details

Applicant: Fotona D.O.O.
Product code: Code QPL
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2024-06-20
Decision date: 2025-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ljubljana, SI

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.