# K140711: Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug, Comfortear Lacrisolve Punctum Plug,

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Bioteck, Inc.
- Decided: Jun 20, 2014 after 91 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: 1 generation back to K890919 (1989). 2 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K030300: Opaque Herrick Lacrimal Plug, Lacrimedics, Inc. (2003) Summary page 2.
- K890919: Temporary Intracanalicular Collagen Implant, Eagle Vision, Inc. (1989) Summary page 2.

## Most influential descendants
- K150288: PDO Absorbable Punctum Plug (2015), 3 descendants of its own
- K162361: Soft Plug Extended Duration 180 Canalicular Plug (2017), 2 descendants of its own
- 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 Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to: * Determine the potential effectiveness of a permanent occlusion, * 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, and * Temporarily treat dry eye after ocular surgery

Source page: https://510kreport.com/device/K140711
Methodology: https://510kreport.com/methodology