QBR
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intranasal Electrostimulation Device For Dry Eye Symptoms
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5310
- Medical specialty
- Ophthalmic
- FDA definition
- This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| TrueTear Intranasal Tear Neurostimulator (K193589) | Allergan | 2020-08-31 | + Add |
| TrueTear Intranasal Tear Neurostimulator (DEN170086) | Allergan | 2018-05-17 |
Track QBR automatically
Every clearance here is in the API, with alerts when new ones post.