FDA.reportPublic FDA data

De Novo DEN080006

Device
ULTHERA SYSTEM, MODEL 8850-0001
Contact
randall e miller
De Novo number
DEN080006
Product code
OHV
Regulation
878.4590
Classification name
focused ultrasound for tissue heat or mechanical cellular disruption
Decision
granted (DENG)
Decision date
2009-09-11
Date received
2008-04-11
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
OHV
Device name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4590
Implant
N
Life sustain/support
N