FDA product code QBR: Intranasal Electrostimulation Device For Dry Eye Symptoms
QBR is the FDA product code for intranasal electrostimulation device for dry eye symptoms. It is a Class II device, regulated under 21 CFR 886.5310 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under QBR. The average 510(k) review took 252 days (median 252). 1 De Novo request was granted under it.
Definition
This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.
Classification
| Field | Value |
|---|---|
| Device name | Intranasal Electrostimulation Device For Dry Eye Symptoms |
| Device class | Class II |
| Regulation | 21 CFR 886.5310 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for QBR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 252 |
Compare with all 510(k) review times · Search every QBR clearance
Top QBR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Allergan | 1 | 2020-08-31 |
Most recent QBR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193589 | Allergan | TrueTear Intranasal Tear Neurostimulator | 2020-08-31 | 252 |
Recalls for QBR devices
openFDA lists no recalls for product code QBR.
Frequently asked questions
What is FDA product code QBR?
QBR is the FDA product code for intranasal electrostimulation device for dry eye symptoms. It is a Class II device, regulated under 21 CFR 886.5310 and reviewed by the Ophthalmic panel.
What device class is QBR?
Class II, regulation 21 CFR 886.5310. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBR?
Across 1 cleared submissions the average was 252 days from receipt to decision (median 252).
Which companies have the most QBR clearances?
Allergan (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBR
- Run a recall and safety report across every QBR manufacturer
- Watch product code QBR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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