PLX — Tear Duct Occluder Class I
FDA product code PLX covers "Tear Duct Occluder", a Class I medical device regulated under 21 CFR 886.5838. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PLX
- Device Class
- Class I
- Regulation Number
- 886.5838
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN140022 | innovatex | GLAUCOMA COMPANION | April 20, 2016 |