QKV
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electromechanical Tear Stimulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5305
- Medical specialty
- Ophthalmic
- FDA definition
- This device type is a non-implantable device intended to increase tear production via mechanical stimulation.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| iTEAR100 Neurostimulator (K213623) | Olympic Ophthalmics | 2022-03-16 |
| iTEAR Neurostimulator (DEN190026) | Olympic Ophthalmics, Inc. | 2020-05-01 |
Track QKV automatically
Every clearance here is in the API, with alerts when new ones post.