QKV

Electromechanical Tear Stimulator

Product code

QKV

Device name

Electromechanical Tear Stimulator

Device class

Class 2

21 CFR

21 CFR 886.5305

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

This device type is a non-implantable device intended to increase tear production via mechanical stimulation.

Definition text from the FDA device classification database (U.S. federal government work, public domain).