Oculeve Intranasal Tear Neurostimulator Device

Intranasal Electrostimulation Device

OCULEVE, INC.

The following data is part of a De Novo classification by Oculeve, Inc. with the FDA for Oculeve Intranasal Tear Neurostimulator Device.

Pre-market Notification Details

DeNovo IDDEN160030
Device Name:Oculeve Intranasal Tear Neurostimulator Device
ClassificationIntranasal Electrostimulation Device
Applicant OCULEVE, INC. 395 Oyster Point Blvd suite 501 South San Francisco,  CA  94080
ContactAndy Doraiswamy
Product CodePQJ  
CFR Regulation Number886.5300 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardOphthalmic
Classification AdvisoryOphthalmic
TypeDirect
Date Received2016-07-07
Decision Date2017-04-24
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850102007205 DEN160030 000
00850102007199 DEN160030 000
00850102007182 DEN160030 000
00850102007175 DEN160030 000
00850102007168 DEN160030 000
00850102007151 DEN160030 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.