FibroLux— 510(k) K212189

Substantially Equivalent

Multi Radiance Medical

FDA 510(k) clearance K212189 for FibroLux, Substantially Equivalent on 2022-09-02. Applicant: Multi Radiance Medical. Device class: 2.

Clearance details

Applicant: Multi Radiance Medical
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2021-07-13
Decision date: 2022-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

Download summary PDF View on FDA.gov ↗

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