FDA product code QZP: Camera, Ophthalmic, Non-Prescription
QZP is the FDA product code for camera, ophthalmic, non-prescription. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel. Devices under QZP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Non-prescription ophthalmic camera is an AC or battery-powered device intended to take photographs of the eye and the surrounding area. The device is intended to be operated by a lay person and provide images available for evaluation by an eye care professional.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Ophthalmic, Non-Prescription |
| Device class | Class II |
| Regulation | 21 CFR 886.1120 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for QZP devices
openFDA lists no recalls for product code QZP.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J8499 — Prescription drug, oral, non chemotherapeutic, nos
Frequently asked questions
What is FDA product code QZP?
QZP is the FDA product code for camera, ophthalmic, non-prescription. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel.
What device class is QZP?
Class II, regulation 21 CFR 886.1120. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QZP
- Run a recall and safety report across every QZP manufacturer
- Watch product code QZP 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.