The following data is part of a premarket notification filed by Olympic Ophthalmics with the FDA for Itear100 Neurostimulator.
| Device ID | K213623 |
| 510k Number | K213623 |
| Device Name: | ITEAR100 Neurostimulator |
| Classification | Electromechanical Tear Stimulator |
| Applicant | Olympic Ophthalmics 400 NW Gilman Blvd No 1370 Issaquah, WA 98027 |
| Contact | Michael Gertner |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | QKV |
| CFR Regulation Number | 886.5305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-16 |
| Decision Date | 2022-03-16 |