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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 K120257
FOIA Releasable 510(k) K120257
Device Name MLS, ZERONA-AD
Applicant
Erchonia Medical, Inc.
5401 S. Cottonwood Ct.
Greenwood Village,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Erchonia Medical, Inc.
5401 S. Cottonwood Ct.
Greenwood Village,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.5400
Classification Product Code
OLI  
Subsequent Product Code
GEX  
Date Received01/27/2012
Decision Date 05/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Clinical Trials NCT01376037
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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