QKV · Class II · 21 CFR 886.5305

FDA Product Code QKV: Electromechanical Tear Stimulator

This Device Type Is A Non-implantable Device Intended To Increase Tear Production Via Mechanical Stimulation.

Leading manufacturers include Olympic Ophthalmics, Inc. and Olympic Ophthalmics.

2
Total
1
Cleared
236d
Avg days
2020
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Electromechanical Tear Stimulator Devices (Product Code QKV)

2 devices
1–2 of 2
Cleared Mar 16, 2022
iTEAR100 Neurostimulator
K213623
Olympic Ophthalmics
Ophthalmic · 120d
Not Cleared May 01, 2020
iTEAR Neurostimulator
DEN190026
Olympic Ophthalmics, Inc.
Ophthalmic · 352d

About Product Code QKV - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QKV since 2020, with 1 receiving FDA clearance (average review time: 236 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.