# K172645: iLux Instrument, iLux Disposable

- Pathway: 510(k) (Traditional)
- Applicant: Tear Film Innovations, Inc.
- Decided: Dec 26, 2017 after 116 days
- Product code: ORZ (Eyelid Thermal Pulsation System)
- Device class: 2
- Regulation: 21 CFR 886.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN100017 (2011). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133127: Lipiflow Thermal Pulsation System, Tearscience, Inc. (2013) Summary page 4.

## Most influential descendants
- K240512: Tixel i (TXLI0001) (2024), 0 descendants of its own
- K200400: Systane iLux2 (2020), 0 descendants of its own

## Indications for use
The iLux System is indicated for the application of localized heat and pressure therapy in adult patients with chronic diseases of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye.

Source page: https://510kreport.com/device/K172645
Methodology: https://510kreport.com/methodology