FDA product code PQJ: Intranasal Electrostimulation Device
PQJ is the FDA product code for intranasal electrostimulation device. It is a Class II device, regulated under 21 CFR 886.5300 and reviewed by the Ophthalmic panel. Devices under PQJ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
This device type is intended to temporarily increase tear production using neurostimulation in adult patients.
Classification
| Field | Value |
|---|---|
| Device name | Intranasal Electrostimulation Device |
| Device class | Class II |
| Regulation | 21 CFR 886.5300 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for PQJ devices
openFDA lists no recalls for product code PQJ.
Frequently asked questions
What is FDA product code PQJ?
PQJ is the FDA product code for intranasal electrostimulation device. It is a Class II device, regulated under 21 CFR 886.5300 and reviewed by the Ophthalmic panel.
What device class is PQJ?
Class II, regulation 21 CFR 886.5300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PQJ
- Run a recall and safety report across every PQJ manufacturer
- Watch product code PQJ 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times