# K193589: TrueTear Intranasal Tear Neurostimulator

- Pathway: 510(k) (Traditional)
- Applicant: Allergan
- Decided: Aug 31, 2020 after 252 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
Longest line of descent: 1 generation back to DEN170086 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170086: TrueTear Intranasal Tear Neurostimulator, Allergan (2018) Summary page 4.

## 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/K193589
Methodology: https://510kreport.com/methodology