# DEN170086: TrueTear Intranasal Tear Neurostimulator

- Pathway: De Novo (Direct)
- Applicant: Allergan
- Decided: May 17, 2018 after 206 days
- Product code: QBR (Intranasal Electrostimulation Device For Dry Eye Symptoms)
- Device class: 2
- Regulation: 21 CFR 886.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K193589: TrueTear Intranasal Tear Neurostimulator (2020), 0 descendants of its own

## Indications for use
The TrueTear Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.

Source page: https://510kreport.com/device/DEN170086
Methodology: https://510kreport.com/methodology