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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 K191257
Device Name Erchonia EVRL
Applicant
Erchonia Corporation
650 Atlantis Road
Melbourne,  FL  32904
Applicant Contact Steven Shanks
Correspondent
Erchonia Corporation
650 Atlantis Road
Melbourne,  FL  32904
Correspondent Contact Steven Shanks
Regulation Number890.5500
Classification Product Code
NHN  
Subsequent Product Code
GEX  
Date Received05/10/2019
Decision Date 08/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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