FDA.reportPublic FDA data

De Novo DEN100017

Device
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
Contact
christy moeny
De Novo number
DEN100017
Product code
ORZ
Regulation
886.5200
Classification name
eyelid thermal pulsation system
Decision
granted (DENG)
Decision date
2011-06-28
Date received
2010-08-09
Classification advisory
Ophthalmic
Review advisory
Ophthalmic
Type
Post-NSE

Current FDA Classification#

Product code
ORZ
Device name
Eyelid Thermal Pulsation System
Medical specialty
Ophthalmic
Device class
2
Regulation
886.5200
Implant
N
Life sustain/support
N