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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 K251903
Device Name Erchonia DPN Laser (Model# EVRL)
Applicant
Erchonia Corporation
112 Southchase Blvd.
Fountain Inn,  SC  29644
Applicant Contact Travis Sammons
Correspondent
Erchonia Corporation
112 Southchase Blvd.
Fountain Inn,  SC  29644
Correspondent Contact Travis Sammons
Regulation Number890.5500
Classification Product Code
NHN  
Date Received06/20/2025
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Clinical Trials NCT05291975
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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