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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 K123237
FOIA Releasable 510(k) K123237
Device Name ZERONA 2.0 LASER
Applicant
Erchonia Corporation
33 Golden Eagle Ln.
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Erchonia Corporation
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.5400
Classification Product Code
OLI  
Date Received10/16/2012
Decision Date 01/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Clinical Trials NCT01292538
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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