# K200400: Systane iLux2

- Pathway: 510(k) (Traditional)
- Applicant: Tear Film Innovations, Inc.
- Decided: May 21, 2020 after 93 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: 4 generations back to DEN100017 (2011). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172645: iLux Instrument, iLux Disposable, Tear Film Innovations, Inc. (2017) Summary page 4.

## Indications for use
The Systane iLux® is indicated for the application of localized heat and pressure therapy in adult patients with Meibomian Gland Dysfunction (MGD), which is associated with evaporative dry eye, and to capture/store digital images and video of the meibomian glands.

Source page: https://510kreport.com/device/K200400
Methodology: https://510kreport.com/methodology