MR5 Activ Pro— 510(k) K254024

Name: FDA 510(k) clearance K254024
Creator: U.S. Food and Drug Administration
Published: 2026-05-19

Substantially Equivalent

Multi Radiance Medical, Inc.

FDA 510(k) clearance K254024 for MR5 Activ Pro, Substantially Equivalent on 2026-05-19. Applicant: Multi Radiance Medical, Inc.. Device class: 2.

Summary

Multi Radiance Medical's MR5 Activ Pro is filed under NHN, which the record names "Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy".

Class II, 21 CFR 890.5500. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).

Multi Radiance filed from Solon, Ohio. The decision came 154 calendar days after receipt (December 16, 2025 to May 19, 2026).

Clearance details

Applicant: Multi Radiance Medical, Inc.
Product code: Product code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2025-12-16
Decision date: 2026-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

Download summary PDF View on FDA.gov ↗

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