Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5305](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5305) → QKV — Electromechanical Tear Stimulator

# QKV · Electromechanical Tear Stimulator

_Ophthalmic · 21 CFR 886.5305 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/QKV

## Overview

- **Product Code:** QKV
- **Device Name:** Electromechanical Tear Stimulator
- **Regulation:** [21 CFR 886.5305](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5305)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.

## Classification Rationale

Class II (special controls). The special controls for this device are:

## Special Controls

In combination with the general controls of the FD&C Act, the electromechanical tear stimulator is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
(i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;
(ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and
(iii) Use life testing.
(3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.
(4) All patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Physician and patient labeling must include:
(i) A detailed summary of the device's technical parameters;
(ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;
(iii) Information related to electromagnetic compatibility classification;
(iv) Instructions on how to clean and maintain the device;
(v) A summary of the clinical performance testing conducted with the device;
(vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and
(vii) Information on how the device operates and the typical sensations experienced during treatment.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K213623](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/QKV/K213623.md) | iTEAR100 Neurostimulator | Olympic Ophthalmics | Mar 16, 2022 | SESE |
| [DEN190026](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/QKV/DEN190026.md) | iTEAR Neurostimulator | Olympic Ophthalmics, Inc. | May 1, 2020 | DENG |

## Top Applicants

- Olympic Ophthalmics — 1 clearance
- Olympic Ophthalmics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/QKV](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/QKV)

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