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

    AYON Body Contouring System™ (AYON SYSTEM)

    K Number: K253396 · Decision May 8, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    57
    Applicant Total
    6
    Review Days
    220

    Basic Information

    Device Name
    AYON Body Contouring System™ (AYON SYSTEM)
    K Number
    K253396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apyx Medical Corporation
    Date Received
    September 30, 2025
    Decision Date
    May 8, 2026
    Product Code
    QPB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QPB System, Suction, Lipoplasty For Removal

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