# K222164: Visant Medical Canalicular Plug

- Pathway: 510(k) (Traditional)
- Applicant: Visant Medical, Inc.
- Decided: Dec 23, 2022 after 155 days
- Product code: LZU (Plug, Punctum)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K946357 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040912: Hydrogel Canalicular Plug, Partners IN Biomaterials, Inc. (2004) Summary page 4.

## Indications for 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.

Source page: https://510kreport.com/device/K222164
Methodology: https://510kreport.com/methodology