BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Silk’n Toothwave

    K Number: K214078 · Decision Jan 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    15
    Review Days
    382

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    Basic Information

    Device Name
    Silk’n Toothwave
    K Number
    K214078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6866
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Home Skinovations , Ltd.
    Date Received
    December 27, 2021
    Decision Date
    January 13, 2023
    Product Code
    QMJ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QMJ Powered Radiofrequency Toothbrush

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