510(k) DEN160030
DEN160030 is an FDA 510(k) premarket notification submitted by Oculeve, Inc. for the device "Oculeve Intranasal Tear Neurostimulator Device". The FDA issued a decision of De Novo Granted on April 24, 2017. The device falls under product code PQJ (Intranasal Electrostimulation Device), a Class II device regulated under 21 CFR 886.5300.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 24, 2017
- Date Received
- July 7, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intranasal Electrostimulation Device
- Device Class
- Class II
- Regulation Number
- 886.5300
- Review Panel
- OP
- Submission Type
This device type is intended to temporarily increase tear production using neurostimulation in adult patients.