FDA.reportPublic FDA data

De Novo DEN110004

Device
CABOCHON SYSTEM
Contact
ben brian
De Novo number
DEN110004
Product code
OUP
Regulation
878.4790
Classification name
powered surgical instrument for improvement in the appearance of cellulite
Decision
granted (DENG)
Decision date
2013-07-12
Date received
2011-10-31
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
OUP
Device name
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4790
Implant
N
Life sustain/support
N