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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 eve or lipid deficiency dry eve.

The LipiFlow® Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent pressure to the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow® System is comprised of a physician interface (Control component labeled as "Console") and a patient interface (Disposable component labeled as "Activator II"). The Console provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids with the Activator II Disposable. This 510(k) submission is for modification of the proposed Activator II Disposable (Model LFD-2100) and labeling changes to the predicate Activator II (Model LFD-2000). The proposed devices have the same intended use, indications for use and fundamental scientific technology as the legally marketed predicate device. The proposed Activator II Model (LFD-2100) is the same as the predicate Activator II Models (LFD-2000) except for the following: - . Eye Cup Assembly Redesign: the Activator II eye cup, which consists of the bladder and substrate, will be redesigned to allow the eye cup to be manufactured as a single versus seven-piece molded bladder assembly while still attaching to the lid warmer in the same location. - Back Surface Overmold Redesign: the back surface overmold of the lid warmer will be ● redesigned to accommodate the modified Single Piece Eye Cup. The design change will be limited to the removal of the t-extrusion in the Z-direction used to hold the original Eye Cup in position. - The material for the non-patient contact bladder substrate will be changed from Valox (PBT) to polycarbonate. The labeling for the predicate Activator II Model (LFD-2000) will also be updated to replace special storage and handling conditions with the statement: "Store at room temperature". Compared to the predicate Activator II Model, the patient interface portion of the proposed Activator II Model is identical in patient-contact materials, electrical safety, packaging, sterility, shelf-life, method of preventing re-use, and temperature and pressure performance and safety. The proposed Activator II Model (LFD-2100) will remain fully backwards compatible with the current LipiFlow Console and Semi-permanent Cable. There are no changes to the Console and Cable from the predicate device.