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510(k) Data Aggregation
K Number
K222164Device Name
Visant Medical Canalicular Plug
Manufacturer
Visant Medical, Inc.
Date Cleared
2022-12-23
(155 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Visant Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Visant Medical Canalicular Plug is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.
Device Description
The Visant Medical Canalicular Plug is designed to temporarily block tear drainage by the occlusion of the canaliculus of one or both eyelids in a given patient, thus maintaining lubricating tears on the surface of the eye. The Visant Plug consists of a transparent hydrogel, manufactured from cross-linked hyaluronic acid, that is designed for insertion into the canaliculus.
The Visant Medical Canalicular Plug is inserted into the lower canaliculus of the patient's eyelid by the healthcare practitioner, using a commercially available lacrimal cannula attached to the 0.6 mL gel-filled syringe which pushes the gel into the lower punctum until the recommended volume of gel (0.2 mL) is inserted.
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