FDA product code PLX

Tear Duct Occluder

Ophthalmic·Class 1·21 CFR 886.5838
US regulatory classifications
US Product Code (FDA)
PLX
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 886.5838
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Tear Duct Occluder is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.