# K040231: Inteliport Occluding Device

- Pathway: 510(k) (Traditional)
- Applicant: Alcon, Inc.
- Decided: Jul 13, 2004 after 162 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: 2 generations back to K945906 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980437: Silicone Punctal Plug, Oasis Medical, Inc. (1998) Summary page 2.

## Indications for use
The InteliPORT® Occluding Device is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by occluding the lacrimal drainage system in order to increase tear volume. The InteliPORT® Occluding Device may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. Other patients that may benefit are: patients with arthritis, patients taking systemic or topical medications known to produce dry eyes, contact wearers who experience dry eye related problems, and patients who live in dry climates, or spend extended periods of time in low humidity environments (such as air conditioning). Topical eye drops may be more effective with punctal occlusion because tear drainage will be retarded, and tear breakup time extended.

Source page: https://510kreport.com/device/K040231
Methodology: https://510kreport.com/methodology