BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)

    K Number: K230597 · Decision Apr 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    102
    Applicant Total
    11
    Review Days
    56

    Basic Information

    Device Name
    Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
    K Number
    K230597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Tree Ventures Europe B.V.
    Date Received
    March 3, 2023
    Decision Date
    April 28, 2023
    Product Code
    OAP
    Advisory Committee
    Physical Medicine
    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
    OAP Laser, Comb, Hair

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