# K162361: Soft Plug Extended Duration 180 Canalicular Plug

- Pathway: 510(k) (Traditional)
- Applicant: Oasis Medical, Inc.
- Decided: Apr 17, 2017 after 237 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: 3 generations back to K890919 (1989). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150288: PDO Absorbable Punctum Plug, Riverpoint Medical (2015) Summary page 4.

## Most influential descendants
- K241229: Hello,eyes® BIO Plug (2024), 0 descendants of its own
- K213988: SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (2022), 0 descendants of its own

## Indications for use
The Soft Plug® Extended Duration 180 Canalicular Plugs are intended to temporarily block tear drainage 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/K162361
Methodology: https://510kreport.com/methodology