BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PureLift Pro Edition

    K Number: K230506 · Decision Jun 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    77
    Applicant Total
    1
    Review Days
    117

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    Basic Information

    Device Name
    PureLift Pro Edition
    K Number
    K230506
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xtreem Pulse
    Date Received
    February 24, 2023
    Decision Date
    June 21, 2023
    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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