510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN140022Unknown

Glaucoma Companion

Innovatex, Inc., Weston MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN140022 is the FDA 510(k) clearance record for GLAUCOMA COMPANION, a class I device, cleared for Innovatex, Inc. on under FDA product code PLX (Tear Duct Occluder). FDA's definition for product code PLX 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...". FDA records list one 510(k) clearance for Innovatex, Inc. As of , FDA records show no recalls naming DEN140022.

Clearance record

Decision date
Received
(642 days to decision)
Product code
PLX Tear Duct Occluder
Regulation
21 CFR 886.5838
Device class
Class I
Review panel
Ophthalmic
Applicant
Innovatex, Inc. 150 Buckskin Dr., Weston MA
Third party review
No

Clearances, product code PLX

Trailing 12 months

FDA records hold no clearances under product code PLX in the trailing twelve months.

FDA records show no clearances under product code PLX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PLX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260