The following data is part of a De Novo classification by Olympic Ophthalmics, Inc. with the FDA for Itear Neurostimulator.
| DeNovo ID | DEN190026 |
| Device Name: | ITEAR Neurostimulator |
| Classification | Electromechanical Tear Stimulator |
| Applicant | Olympic Ophthalmics, Inc. 400 Nw Gilman Blvd. #1370 Issaquah, WA 98027 |
| Contact | Michael Gertner |
| Product Code | QKV |
| CFR Regulation Number | 886.5305 [🔎] |
| 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 | 2019-05-15 |
| Decision Date | 2020-05-01 |
| Reclassification Order: | Reclassification Order |