BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Medi Lift Essential Eye Mask

    K Number: K250618 · Decision Oct 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    243

    Basic Information

    Device Name
    Medi Lift Essential Eye Mask
    K Number
    K250618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ya-Man, Ltd.
    Date Received
    February 28, 2025
    Decision Date
    October 29, 2025
    Product Code
    NFO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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    Other Clearances by Ya-Man, Ltd.

    K Number Device Name
    K244048 Medi Lift Mask
    K220198 Medi Lift PLUS
    K112016 L-SER KO LAMP
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    K011021 LASER 20