LipiFlow Activator Clear (Single Unit)

About the Product

TearScience Activator Clear is the sterile, single use disposable applied to the eye during a LipiFlow treatment, model LFD-2100, catalog number 0803-5001, supplied as a box of one. It is packaged sterile and requires no sterilization before use, and it is a prescription device.

This is the single use disposable that a practice buys as a consumable for the LipiFlow Thermal Pulsation System, and it fits that system only. It has a translucent, vaulted design that sits over the eye, and a pair is placed over both eyes for a bilateral treatment. During the treatment the console delivers warmth and intermittent pressure through the Activator, with heat applied to the inner eyelid surface at 42.5 degrees Celsius. It is supplied sterile and is discarded after one patient.

Specifications

Regulatory

The Activator is the applicator for the LipiFlow Thermal Pulsation System. That system is a Class II device under product code ORZ, eyelid thermal pulsation system, 21 CFR 886.5200, cleared under 510(k) K192623 to TearScience, Inc. on 22 October 2019.

Cleared Indications for Use of the LipiFlow Thermal Pulsation System:

The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.