# K213623: iTEAR100 Neurostimulator

- Pathway: 510(k) (Traditional)
- Applicant: Olympic Ophthalmics
- Decided: Mar 16, 2022 after 120 days
- Product code: QKV (Electromechanical Tear Stimulator)
- Device class: 2
- Regulation: 21 CFR 886.5305
- 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 DEN190026 (2020). 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)
- DEN190026: iTEAR Neurostimulator, Olympic Ophthalmics, Inc. (2020) Summary page 4.

## Indications for use
The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.

Source page: https://510kreport.com/device/K213623
Methodology: https://510kreport.com/methodology