De Novo DEN160030

Device
Oculeve Intranasal Tear Neurostimulator Device
Contact
andy doraiswamy
De Novo number
DEN160030
Product code
PQJ
Regulation
886.5300
Classification name
intranasal electrostimulation device
Decision
granted (DENG)
Decision date
2017-04-24
Date received
2016-07-07
Classification advisory
Ophthalmic
Review advisory
Ophthalmic
Type
Direct

Current FDA Classification#

Product code
PQJ
Device name
Intranasal Electrostimulation Device
Medical specialty
Ophthalmic
Device class
2
Regulation
886.5300
Implant
N
Life sustain/support
N