PLX · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.5838
Classification
FDA Product Code
PLX
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.5838
Review panel
OP
Medical specialty
Ophthalmic
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.