Not Cleared Direct

TrueTear Intranasal Tear Neurostimulator (DEN170086) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170086 · Allergan · Ophthalmic device
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May 2018
Decision
206d
Days
Class 2
Risk

DEN170086 is an FDA 510(k) submission (not cleared) for the TrueTear Intranasal Tear Neurostimulator. Classified as Intranasal Electrostimulation Device For Dry Eye Symptoms (product code QBR), Class II - Special Controls.

Submitted by Allergan (Irvine, US). The FDA issued a Not Cleared (DENG) decision on May 17, 2018 after a review of 206 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5310 - the FDA ophthalmic device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Ophthalmic review framework.

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Submission Details

510(k) Number DEN170086 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 23, 2017
Decision Date May 17, 2018
Days to Decision 206 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 110d · This submission: 206d
Pathway characteristics

Device Classification

Product Code QBR Intranasal Electrostimulation Device For Dry Eye Symptoms
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5310
Definition This Device Type Is Intended To Temporarily Increase Tear Production Using Neurostimulation To Improve Dry Eye Symptoms. For Prescription Use Only.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.