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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 K143007
Device Name Erchonia Zerona Z6 OTC
Applicant
ERCHONIA CORPORATION
2021 COMMERCE DRIVE
MCKINNEY,  TX  75069
Applicant Contact Steve Shanks
Correspondent
REGULATORY INSIGHT, INC.
33 Golden Eagle Lane
Litteton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.5400
Classification Product Code
OLI  
Date Received10/20/2014
Decision Date 01/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Clinical Trials NCT02167867
Reviewed by Third Party No
Combination Product No
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