FDA product code PLZ: Ocular Pattern Recorder
PLZ is the FDA product code for ocular pattern recorder. It is a Class II device, regulated under 21 CFR 886.1925 and reviewed by the Ophthalmic panel. Devices under PLZ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation.
Classification
| Field | Value |
|---|---|
| Device name | Ocular Pattern Recorder |
| Device class | Class II |
| Regulation | 21 CFR 886.1925 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for PLZ devices
openFDA lists no recalls for product code PLZ.
Frequently asked questions
What is FDA product code PLZ?
PLZ is the FDA product code for ocular pattern recorder. It is a Class II device, regulated under 21 CFR 886.1925 and reviewed by the Ophthalmic panel.
What device class is PLZ?
Class II, regulation 21 CFR 886.1925. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PLZ
- Run a recall and safety report across every PLZ manufacturer
- Watch product code PLZ 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