FDA product code QBT: Artificial Iris
QBT is the FDA product code for artificial iris. It is a Class III device, reviewed by the Ophthalmic panel. Devices under QBT reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Artificial iris is intended to be implanted to replace the natural iris of the eye.
Classification
| Field | Value |
|---|---|
| Device name | Artificial Iris |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QBT devices
openFDA lists no recalls for product code QBT.
Frequently asked questions
What is FDA product code QBT?
QBT is the FDA product code for artificial iris. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is QBT?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QBT
- Run a recall and safety report across every QBT manufacturer
- Watch product code QBT 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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