BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    PDT-FACE

    K Number: K192295 · Decision May 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    50
    Applicant Total
    10
    Review Days
    252

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    Basic Information

    Device Name
    PDT-FACE
    K Number
    K192295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Adss Development Co., Ltd.
    Date Received
    August 23, 2019
    Decision Date
    May 1, 2020
    Product Code
    OLP
    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
    OLP Over-The-Counter Powered Light Based Laser For Acne

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    Other Clearances by Beijing Adss Development Co., Ltd.

    K Number Device Name
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