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 |