DeviceClearance

Product code PLX— Ophthalmic

GLAUCOMA COMPANION

Classification name
Tear Duct Occluder
Device class
Class 1
Regulation
21 CFR 886.5838
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PLX under 21 CFR 886.5838, via openFDA

Market context for product code PLX

FDA has cleared 1 device under product code PLX, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code PLX

Recent clearances under product code PLX

Data sourced from openFDA. This site is unofficial and independent of the FDA.