PLX · Tear Duct Occluder
Ophthalmic · 21 CFR 886.5838 · Class 1
Overview
| Product Code | PLX |
|---|---|
| Device Name | Tear Duct Occluder |
| Regulation | 21 CFR 886.5838 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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 | GLAUCOMA COMPANION | Innovatex, Inc. | Apr 20, 2016 | DENG |
Top Applicants
- Innovatex, Inc. — 1 clearance
