# K213988: SOFT PLUG Extended Duration 180 Tapered Canalicular Plug

- Pathway: 510(k) (Traditional)
- Applicant: Oasis Medical, Inc.
- Decided: Jun 3, 2022 after 165 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: 4 generations back to K890919 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162361: Soft Plug Extended Duration 180 Canalicular Plug, Oasis Medical, Inc. (2017) Summary page 4.

## Indications for use
The SOFT PLUG Extended Duration 180 Canalicular Plugs and the SOFT PLUG Extended Duration 180 Tapered Canalicular Plugs are intended to temporarily block tear flow by the occlusion of the canaliculus in order to: - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases. - Temporarily enhance the efficacy of topical medications or ocular lubricants. - Temporarily treat contact lens intolerance secondary to dry eye, - Temporarily treat dry eye after ocular surgery. and - Determine the potential effectiveness of permanent occlusion.

Source page: https://510kreport.com/device/K213988
Methodology: https://510kreport.com/methodology