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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 K121695
Device Name ERCHONIA ZERONA
Original Applicant
ERCHONIA CORPORATION
5401 s. cottonwood ct.
greenwood village,  CO  80121
Original Contact kevin walls
Regulation Number878.5400
Classification Product Code
OLI  
Date Received06/07/2012
Decision Date 08/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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