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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K251843
Device Name Erchonia 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 Number878.4810
Classification Product Code
OLP  
Date Received06/16/2025
Decision Date 09/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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