FDA.reportPublic FDA data

De Novo DEN090008

Device
ERCHONIA ML SCANNER (MLS)
Contact
kevin walls
De Novo number
DEN090008
Product code
OLI
Regulation
878.5400
Classification name
fat reducing low level laser
Decision
granted (DENG)
Decision date
2010-08-24
Date received
2009-01-05
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
OLI
Device name
Fat Reducing Low Level Laser
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.5400
Implant
N
Life sustain/support
N