FDA product code PLX: Tear Duct Occluder
PLX is the FDA product code for tear duct occluder. It is a Class I device, regulated under 21 CFR 886.5838 and reviewed by the Ophthalmic panel. Devices under PLX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A nasolacrimal compression device is a device used to compress the nasolacrimal ducts to reduce drainage by means of temporary occlusion of the nasolacrimal system. The device may include a nose piece attached to a frame to apply pressure to the duct.
Classification
| Field | Value |
|---|---|
| Device name | Tear Duct Occluder |
| Device class | Class I |
| Regulation | 21 CFR 886.5838 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for PLX devices
openFDA lists no recalls for product code PLX.
Frequently asked questions
What is FDA product code PLX?
PLX is the FDA product code for tear duct occluder. It is a Class I device, regulated under 21 CFR 886.5838 and reviewed by the Ophthalmic panel.
What device class is PLX?
Class I, regulation 21 CFR 886.5838. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PLX
- Run a recall and safety report across every PLX manufacturer
- Watch product code PLX 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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