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PLX

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Tear Duct Occluder
Device class
Class I (low risk)
Regulation
21 CFR 886.5838
Medical specialty
Ophthalmic
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.
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RecordFirmDate
GLAUCOMA COMPANION (DEN140022)Innovatex, Inc.2016-04-20

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