FDA product code QIU: Intense Pulsed Light Device For Managing Dry Eye
QIU is the FDA product code for intense pulsed light device for managing dry eye. It is a Class II device, regulated under 21 CFR 886.5201 and reviewed by the Ophthalmic panel. Devices under QIU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
Classification
| Field | Value |
|---|---|
| Device name | Intense Pulsed Light Device For Managing Dry Eye |
| Device class | Class II |
| Regulation | 21 CFR 886.5201 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for QIU devices
openFDA lists no recalls for product code QIU.
Frequently asked questions
What is FDA product code QIU?
QIU is the FDA product code for intense pulsed light device for managing dry eye. It is a Class II device, regulated under 21 CFR 886.5201 and reviewed by the Ophthalmic panel.
What device class is QIU?
Class II, regulation 21 CFR 886.5201. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QIU
- Run a recall and safety report across every QIU manufacturer
- Watch product code QIU 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.