# DEN160030: Oculeve Intranasal Tear Neurostimulator Device

- Pathway: De Novo (Direct)
- Applicant: Oculeve, Inc.
- Decided: Apr 24, 2017 after 291 days
- Product code: PQJ (Intranasal Electrostimulation Device)
- Device class: 2
- Regulation: 21 CFR 886.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation in adult patients.

Source page: https://510kreport.com/device/DEN160030
Methodology: https://510kreport.com/methodology