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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K254024
Device Name MR5 Activ Pro
Applicant
Multi Radiance Medical, Inc.
6521 Davis Industrial Pkwy.
Solon,  OH  44139
Applicant Contact Glenn Persello
Correspondent
Multi Radiance Medical, Inc.
6521 Davis Industrial Pkwy.
Solon,  OH  44139
Correspondent Contact Glenn Persello
Regulation Number890.5500
Classification Product Code
NHN  
Date Received12/16/2025
Decision Date 05/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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