# K970631: Punctual Occluder

- Pathway: 510(k) (Traditional)
- Applicant: Odyssey Medical, Inc.
- Decided: Apr 23, 1997 after 63 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 its predicate without a number.
- (no number) EV - Freeman Punctum Plug: named in the summary without a submission number

## Most influential descendants
- K090938: Flow Controller (2009), 0 descendants of its own

## Indications for use
Punctal Occluders are intended for the treatment of “dry eye” conditions through the total occlusion of individual punctal openings.

Source page: https://510kreport.com/device/K970631
Methodology: https://510kreport.com/methodology