The following data is part of a De Novo classification by Allergan with the FDA for Truetear Intranasal Tear Neurostimulator.
| DeNovo ID | DEN170086 |
| Device Name: | TrueTear Intranasal Tear Neurostimulator |
| Classification | Intranasal Electrostimulation Device For Dry Eye Symptoms |
| Applicant | Allergan 2525 Dupont Drive Irvine, CA 92612 |
| Contact | Nooshin Azizi |
| Product Code | QBR |
| CFR Regulation Number | 886.5310 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Ophthalmic |
| Classification Advisory | Ophthalmic |
| Type | Direct |
| Date Received | 2017-10-23 |
| Decision Date | 2018-05-17 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |