Intranasal Electrostimulation Device For Dry Eye Symptoms

FDA product code QBR · Class II (moderate risk) · 21 CFR 886.5310 · Ophthalmic

This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.

1510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K193589TrueTear Intranasal Tear NeurostimulatorQBR · Traditional Allergan08/31/2020SE