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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 K162578
Device Name Zerona Z6 OTC
Applicant
Erchonia Corporation
650 Atlantis Rd.
Melbourne,  FL  32904
Applicant Contact STEVEN SHANKS
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact KEVIN WALLS
Regulation Number878.5400
Classification Product Code
OLI  
Date Received09/15/2016
Decision Date 12/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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