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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name fat reducing low level laser
De Novo Number DEN090008
510(K) Number K082609
Device Name ERCHONIA ML SCANNER (MLS)
Requester
erchonia medical
5401 s. cottonwood ct.
greenwood village,  CO  80121
Contact kevin walls
Regulation Number878.5400
Classification Product Code
OLI  
Date Received01/05/2009
Decision Date 08/24/2010
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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