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

    Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37

    K Number: K170111 · Decision May 8, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    50
    Applicant Total
    3
    Review Days
    116

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    Basic Information

    Device Name
    Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
    K Number
    K170111
    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
    Pulsaderm, LLC
    Date Received
    January 12, 2017
    Decision Date
    May 8, 2017
    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 Pulsaderm, LLC

    K Number Device Name
    K182501 Hair Laser Headband
    K163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72