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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 focused ultrasound for tissue heat or mechanical cellular disruption
De Novo Number DEN080006
510(K) Number K072505
Device Name ULTHERA SYSTEM, MODEL 8850-0001
Requester
ulthera, inc.
33 s. sycamore st.
mesa,  AZ  85202
Contact randall e miller
Regulation Number878.4590
Classification Product Code
OHV  
Date Received04/11/2008
Decision Date 09/11/2009
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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