De Novo DEN090002

Device
ZELTIQ AESTHETICS DERMAL COOLING DEVICE
Contact
louis-pierre marcoux
De Novo number
DEN090002
Product code
OOK
Regulation
878.4340
Classification name
dermal cooling pack/vacuum/massager
Decision
granted (DENG)
Decision date
2010-08-24
Date received
2009-10-13
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
OOK
Device name
Dermal Cooling Pack/Vacuum/Massager
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4340
Implant
N
Life sustain/support
N