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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fat Reducing Low Level Laser
510(k) Number K252574
Device Name Erchonia CLX (Model # CFL)
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 Number878.5400
Classification Product Code
OLI  
Date Received08/14/2025
Decision Date 12/15/2025
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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