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510(k) Data Aggregation

    K Number
    K250618
    Device Name
    Medi Lift Essential Eye Mask
    Manufacturer
    YA-MAN Ltd.
    Date Cleared
    2025-10-29

    (243 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K220198,K120511
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medi Lift Essential Eye Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.

    Device Description

    The Medi Lift Essential Eye Mask ("Medi Lift Eye") is composed of a mask made of silicone rubber which is worn on the upper part of the user's face, and covers the upper cheek and the periocular region outside the orbital rim. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The mask also contains a heater to warm the upper cheek area for user relaxation, not for a medical purpose. The stimulation and heating functions are provided in separate modes and cannot be used simultaneously. The controllers attached to the mask contain two charging pins which allow for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable that is provided as part of the device. The device is not operated during charging.

    AI/ML Overview

    N/A

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