PLX

Tear Duct Occluder

Product code

PLX

Device name

Tear Duct Occluder

Device class

Class 1

21 CFR

21 CFR 886.5838

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).