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The Systane iLux2 is indicated for the application of localized heat and pressure therapy in adult patients with Melbonian Gland Dysfunction (MGD), which is associated with evaporative dry eye, and to capture/store digital images and video of the meibomian glands.

The Subject Device 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. The device can capture images and videos of the eyelid margin and meibomian glands. These images can be use in meibography (i.e., visual morphology of meibomian glands). In treatment mode, light-based heat is used to warm the eyelid tissue to a target range of 38-44 ℃ to melt the meibum blocking the gland orifices. The Eye Care Professionals (ECP) can apply compression to the eyelid to express the meibum through the orifices. At all times, the amount of the heat and pressure applied is under direct control of the ECP who monitors the response of the glands and the comfort of the patient. The inner eyelid temperature is displayed during the treatment process. The source of heating is lime-green and IR optical radiation produced by LEDs incorporated in the Instrument. Images and video can be captured during treatment. In meibography mode, infrared (IR) light is used in the visualization of meibomian gland morphology. Images can be captured with IR or white light. Video is captured only with white light. The Subject Device consists of the following: - Reusable, Hand-Held Instrument Incorporates hardware, software, and . mechanics to facilitate treatment and imaging. The Instrument incorporates an LCD touchscreen user interface that is used to view the eyelid margin as well as provides instructions to the ECP during use. Selections can be made through the user interface and images/video can be viewed. The Instrument is powered by a rechargeable lithium ion battery. - Docking Station Is used to charge the Instrument's internal battery and transfer . images/video to an external monitor or PC. - . AC Power Supply - Transfer electricity for the AC electrical outlet to the Docking Station. - . Photography Tip (Photo Tip) - Is reusable, up to a specified number of attachments, and when coupled with the Instrument it is used to capture images and video. There is electronics in the Photo Tip that interfaces with the Instrument. The Photo Tip is positioned on the cheek bone or eyebrow. The patient contacting material is biocompatible. - . Smart Tip Patient Interface (Smart Tip) - Is sterile and single-use that when coupled with the Instrument treatment can be provided. There is electronics in the Smart Tip that interfaces with the Instrument. A feature of the Smart Tip is positioned behind the eyelid during the treatment process. The patient contacting material is biocompatible. - USB & HMDI Cable Attaches Docking Station to external monitor/PC. .

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.

The iLux System is a medical device intended for use by Licensed Eye Care Professionals (ECP) to apply localized heat and pressure therapy to adult patients' lower and/or upper eyelids. The il.ux System consists of a hand-held Instrument coupled to a single-use sterile Disposable component that is positioned behind the eyelid. The iLux System allows the ECP to view the eyelid margin through a magnifier, then warm the eyelid tissue to a target range of 40 to 42 °C to melt the meibum blocking the gland orifices and then apply compression to the eyelid to express the melted meibum through the orifices. The inner eyelid temperature and the amount of force applied to the eyelid are both displayed on the Instrument allowing the clinician to titrate the ideal amount of heating and compression to optimize unclogging of the blocked glands. The Disposable is a sterile, single-use component that is attached to the iLux Instrument. It includes all parts intended to contact the patient's eyelid. The iLux Instrument is a handheld device that allows the ECP to view, heat, and compress the portion of the eyelid that is in contact with the Disposable. The source of heating is lime-green and infrared optical radiation produced by LEDs in the Instrument. The ilux Instrument is powered by a rechargeable lithium ion battery. The software Level of Concern is Moderate. Ancillary accessories include the charging stand with AC power supply.