DEN170086 is an FDA 510(k) submission for the TrueTear Intranasal Tear Neurostimulator. This device is classified as a Intranasal Electrostimulation Device For Dry Eye Symptoms (Class II - Special Controls, product code QBR).
Submitted by Allergan (Irvine, US). The FDA issued a Not Cleared (DENG) decision on May 17, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5310. This Device Type Is Intended To Temporarily Increase Tear Production Using Neurostimulation To Improve Dry Eye Symptoms. For Prescription Use Only..
| 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 | - |
| Product Code | QBR - Intranasal Electrostimulation Device For Dry Eye Symptoms |
| Device Class | Class II - 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. |