# K021936: Moist Punctal Plug System

- Pathway: 510(k) (Traditional)
- Applicant: Moist Medical, Inc.
- Decided: Oct 16, 2002 after 126 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K161673: LacriPro Punctum Plug (2016), 0 descendants of its own

## Indications for use
Punctum plugs are indicated for the treatment of dry eye disorder. A condition caused by insufficient moisture in the eye. As a result, one may experience some irritation and discomfort to the eyes. Patients that may benefit from the use of punctum plugs are: sufferers of allergies, cataracts, dry eye secondary to contact lens use, and others who experience dry eye disorders. Specific treatment to stop the outflow of tears via a punctal opening (upper/lower) in order to increase tear flow on the surface of the eye.

Source page: https://510kreport.com/device/K021936
Methodology: https://510kreport.com/methodology