StarFormer, TightWave— 510(k) K221274

Substantially Equivalent

Fotona D.O.O.

FDA 510(k) clearance K221274 for StarFormer, TightWave, Substantially Equivalent on 2023-09-29. Applicant: Fotona D.O.O..

Clearance details

Applicant: Fotona D.O.O.
Product code: Code IPF
Advisory panel: Physical Medicine
Date received: 2022-05-02
Decision date: 2023-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ljubljana, SI

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