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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 K152196
Device Name Erchonia EVRL
Applicant
ERCHONIA CORPORATION
2021 COMMERCE DR
MCKINNEY,  TX  75069
Applicant Contact STEVEN SHANKS
Correspondent
REGULATORY INSIGHT, INC
33 GOLDEN EAGLE LANE
LITTLETON,  CO  80127
Correspondent Contact KEVIN WALLS
Regulation Number890.5500
Classification Product Code
NHN  
Subsequent Product Code
GEX  
Date Received08/05/2015
Decision Date 02/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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