Medi Lift Mask

The Medi Lift Mask is a wearable silicone mask device worn on the lower face that delivers electrical pulses through controllers and electrodes to stimulate facial muscles for cosmetic purposes. It is intended for over-the-counter use and is powered by rechargeable lithium-ion batteries with USB charging capability.

The device is nearly identical to the predicate Medi Lift PLUS (K220198) in all specifications including two controllers with three electrodes each, fixed 10-minute timer, 3.7V lithium-ion battery per controller, Type BF patient leakage current protection, and identical weight (176g) and dimensions. The only difference is a change in the UV varnish material used on the controller housing.

ISO 14971:2019 (risk analysis), ISO 10993-1:2018 (biocompatibility evaluation), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), and ISO 10993-23:2021 (intracutaneous reactivity). Prior testing of the predicate device regarding tensile strength, polycyclic aromatic hydrocarbons, software verification, electrical safety, and electromagnetic compatibility remained applicable.

The subject device shares identical intended use, indications, and technological characteristics with the predicate device except for a single material change—the UV varnish on the controller housing. Since no changes were made to the silicone mask, electrodes, software, or electrical components, the risk analysis determined that prior predicate testing remained valid. New biocompatibility testing of the varnish material showed no different safety or effectiveness concerns, demonstrating the device is as safe and effective as the predicate.