# K972523: Punctual Occluder

- Pathway: 510(k) (Traditional)
- Applicant: Odyssey Medical, Inc.
- Decided: Sep 9, 1997 after 64 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) Odyssey Punctal Occluder: named in the summary without a submission number

## Most influential descendants
- K140352: Veraplug (2014), 0 descendants of its own

## Indications for use
Punctal Occluders (plugs) are indicated for the treatment of “dry eye” syndrome. “Dry eye being a condition where there is insufficient lubrication in the eye and the conjunctive becomes much less moist than normal. This produces pain and discomfort in the eyes. This may occur in any condition that causes scars of the cornea, such as erythema multiforme, trachoma, or corneal burns;” Other patients that may benefit are: cataract patients, patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. Treatment is to stop tear outflow via a specific punctum to enhance tear contact time in certain dry eye conditions. It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.

Source page: https://510kreport.com/device/K972523
Methodology: https://510kreport.com/methodology