# K140026: Collasyn Plug for the Lacrimal Efficiency Test

- Pathway: 510(k) (Traditional)
- Applicant: Lacrimedics, Inc.
- Decided: Jun 3, 2014 after 148 days
- Product code: LZU (Plug, Punctum)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895342 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895342: Collagen Implants for the Lacrimal Efficiency Test, Lacrimedics, Inc. (1989) Summary page 1.

## Recalls of this device
- Nov 26, 2014 · Class III · Z-1081-2015: Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained.

## Indications for use
VisiPlugs provide temporary occlusion of the tear drainage system. VisiPlugs may be used as: a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medications or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).

Source page: https://510kreport.com/device/K140026
Methodology: https://510kreport.com/methodology