BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    DOLORCLAST Focused Shock Waves

    K Number: K243279 · Decision Aug 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    7
    Applicant Total
    28
    Review Days
    301

    Basic Information

    Device Name
    DOLORCLAST Focused Shock Waves
    K Number
    K243279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4685
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.M.S Electro Medical Systems S.A
    Date Received
    October 16, 2024
    Decision Date
    August 13, 2025
    Product Code
    PZL
    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
    PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

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