TearCare MGX System

The TearCare MGX System is an electrically-powered device that delivers controlled heat (41–45°C) to the eyelids for 15 minutes to improve meibomian gland function in adult patients with evaporative dry eye disease caused by meibomian gland dysfunction. It consists of reusable SmartHub and SmartCable components and single-use SmartLids, and is operated by an eye care practitioner in an office setting, optionally followed by manual gland expression using a separate Clearance Assistant tool.

The subject device is technologically identical to the predicate device (K242786) in all material respects: same temperature regulation (±0.7°C, max 47°C), same heating mechanism (polymer-encapsulated resistive element), same battery-DC power source, same 15-minute core therapy protocol, and same SmartLid/SmartHub design. The only change is an optional procedural step allowing eyelid debridement prior to thermal therapy using a new Clearance Assistant Plus tool with a debridement edge.

Biocompatibility per ISO 10993 series (10993-1, 10993-5, 10993-10, 10993-23); electrical safety per IEC 60601-1; electromagnetic compatibility per IEC 60601-1-2; risk management per ISO 14971:2019. Clinical safety and effectiveness evaluated through the OLYMPIA and SAHARA prospective, multicenter, randomized controlled trials.

The TearCare MGX System is substantially equivalent to its predicate because it has identical device classification, product code, and intended use; all thermal, electrical, and safety parameters are unchanged; and clinical data from OLYMPIA and SAHARA studies demonstrate that the optional eyelid debridement procedural addition does not impact device safety or effectiveness, with only 1.7% eyelid-related adverse events comparable to predicate studies without debridement.