FDA 510(k) Application Details - DEN080006

Device Classification Name	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption   More FDA Info for this Device
510(K) Number	DEN080006
Device Name	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant	ULTHERA, INC. 33 SOUTH SYCAMORE STREET MESA, AZ 85202 US Other 510(k) Applications for this Company
Contact	RANDALL E MILLER Other 510(k) Applications for this Contact
Regulation Number	878.4590   More FDA Info for this Regulation Number
Classification Product Code	OHV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2008
Decision Date	09/11/2009
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review