> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Electromechanical Tear Stimulator in Class 2
- URL: https://www.fdaweb.com/electromechanical-tear-stimulator-in-class-2/
- Published: 2022-02-18T12:00:00.000Z
- Updated: 2026-09-14T17:33:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151196

*Federal Register* notice: FDA is classifying the electromechanical tear stimulator into medical device Class 2 (special controls). The action is based on an Olympic Ophthalmics de novo classification request for its iTEAR100 Neurostimulator. The agency has identified it as being a non-implantable device intended to increase tear production via mechanical stimulation. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-02-18/pdf/2022-03540.pdf?ref=fdaweb.com).