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TrueTear Intranasal Tear Neurostimulator

DEN170086 Class II Direct
Decision Date
2018-05-17
Sponsor / Applicant
Allergan

Technical Specification

510(k) Submission ID DEN170086
Product Code QBR
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 886.5310
Decision Date 2018-05-17
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

TrueTear Intranasal Tear Neurostimulator received FDA 510(k) clearance under submission number DEN170086, sponsored by Allergan. The device was reviewed via the Direct premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2018-05-17.

Classification & Regulation

This clearance is catalogued under FDA product code QBR and 21 CFR 886.5310, within the Ophthalmic review panel as a Class II device.