K193589 is an FDA 510(k) clearance 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 Cleared decision on August 31, 2020, 252 days after receiving the submission on December 23, 2019.
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 | K193589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2019 |
| Decision Date | August 31, 2020 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| 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. |