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510(k) DEN170086

TrueTear Intranasal Tear Neurostimulator by Allergan — Product Code QBR

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 17, 2018
Date Received
October 23, 2017
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intranasal Electrostimulation Device For Dry Eye Symptoms
Device Class
Class II
Regulation Number
886.5310
Review Panel
OP
Submission Type

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

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Other clearances for product code QBR

  • K193589 — TrueTear Intranasal Tear Neurostimulator (August 31, 2020)