TearCare MGX System

The TearCare MGX System is a thermal therapy device that applies controlled, localized heat (41-45°C) to the eyelids for 15 minutes, followed by an optional 10-minute warming hold period. It is used to treat evaporative dry eye disease caused by meibomian gland dysfunction (MGD) in adults, and must be used in conjunction with manual expression of the meibomian glands by an eye care practitioner.

The subject device is technologically identical to the predicate device in all material respects: same temperature range and control parameters (41-45°C with ±0.7°C accuracy), same heat generation mechanism (resistive heating element), same thermal safety limits (46.99°C maximum outer eyelid surface temperature), same 15-minute treatment duration with optional warming hold, same reusable SmartHub/SmartCable/Charging Nest components, and same single-use SmartLids. The only change is procedural: updated Instructions for Use include an additional earpiece fitment check step.

ISO 10993-1 (biocompatibility—limited contact duration), ISO 10993-5 (cytotoxicity), ISO 10993-23 (skin irritation), ISO 10993-10 (sensitization and irritation), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (electromagnetic compatibility). Risk management per ISO 14971:2019.

The device is substantially equivalent because it is technologically identical to the predicate in all thermal and safety parameters; there are no changes to heat generation, temperature control, thermal limits, or therapeutic delivery. The only modification is an instructional update for proper earpiece fitment, validated by a clinical study of 21 subjects showing 100% earloop retention during simulated 25-minute treatment. Since the subject device does not change any thermal performance parameters, the predicate's clinical safety data directly applies, and the new fitment instructions reduce positioning risk without altering device function or therapeutic mechanism.