TrueTear Intranasal Tear Neurostimulator— 510(k) K193589

Name: FDA 510(k) clearance K193589
Creator: U.S. Food and Drug Administration
Published: 2020-08-31

Substantially Equivalent

Allergan

FDA 510(k) clearance K193589 for TrueTear Intranasal Tear Neurostimulator, Substantially Equivalent on 2020-08-31. Applicant: Allergan. Device class: 2.

Clearance details

Applicant: Allergan
Product code: Code QBR
Device class: Class 2
Regulation: 21 CFR 886.5310
Advisory panel: Ophthalmic
Date received: 2019-12-23
Decision date: 2020-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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DEN170086 — TrueTear Intranasal Tear Neurostimulator2018-05-17

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