FDA product code PJZ: Camera, Ophthalmic, General-Use
PJZ is the FDA product code for camera, ophthalmic, general-use. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel. Devices under PJZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of diagnostic or aid in diagnosis claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Ophthalmic, General-Use |
| Device class | Class II |
| Regulation | 21 CFR 886.1120 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for PJZ devices
openFDA lists no recalls for product code PJZ.
Frequently asked questions
What is FDA product code PJZ?
PJZ is the FDA product code for camera, ophthalmic, general-use. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel.
What device class is PJZ?
Class II, regulation 21 CFR 886.1120. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PJZ
- Run a recall and safety report across every PJZ manufacturer
- Watch product code PJZ 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.