FDA Product Code
FDA Product Code QKV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.5305
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213623 | iTEAR100 Neurostimulator | Olympic Ophthalmics | 2022-03-16 | Traditional | PDF ↗ |
| DEN190026 | iTEAR Neurostimulator | Olympic Ophthalmics, Inc. | 2020-05-01 | Direct | — |
Product code QKV · Class II · Ophthalmic. Data: openFDA.