Tear Duct Occluder
The Tear Duct Occluder (product code PLX) is a Class 1 ophthalmic device used as a nasolacrimal compression device to compress the nasolacrimal ducts and reduce drainage via temporary occlusion of the nasolacrimal system, regulated under 886.5838. Class 1 devices are subject only to general controls and are generally exempt from 510(k) requirements. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PLX
- Device Class
- FDA class 1
- Regulation Number
- 886.5838
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN140022 | GLAUCOMA COMPANION | Apr 20, 2016 | Unknown | Innovatex, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.