510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PLXClass I

Tear Duct Occluder

21 CFR 886.5838 / Ophthalmic
FDA source (opens on fda.gov)

PLX is the FDA product code for Tear Duct Occluder, a class I device type, regulated under 21 CFR 886.5838. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PLX
Device name
Tear Duct Occluder
FDA 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.
Regulation
21 CFR 886.5838
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PLX

By decision year
1 clearance under product code PLX with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PLX by decision year
YearClearances
20161

Applicants with the most clearances

Product code PLX
Applicants holding the most 510(k) clearances under product code PLX
ApplicantClearances
Innovatex, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code