Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5838](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5838) → PLX — Tear Duct Occluder

# PLX · Tear Duct Occluder

_Ophthalmic · 21 CFR 886.5838 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/PLX

## Overview

- **Product Code:** PLX
- **Device Name:** Tear Duct Occluder
- **Regulation:** [21 CFR 886.5838](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5838)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN140022](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/PLX/DEN140022.md) | GLAUCOMA COMPANION | Innovatex, Inc. | Apr 20, 2016 | DENG |

## Top Applicants

- Innovatex, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/PLX](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/PLX)

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