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QBR — Intranasal Electrostimulation Device For Dry Eye Symptoms Class II

FDA Device Classification

Classification Details

Product Code
QBR
Device Class
Class II
Regulation Number
886.5310
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K193589allerganTrueTear Intranasal Tear NeurostimulatorAugust 31, 2020
DEN170086allerganTrueTear Intranasal Tear NeurostimulatorMay 17, 2018