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

    Looper (Model: ZX-579S)

    K Number: K202055 · Decision Apr 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    50
    Applicant Total
    6
    Review Days
    266

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    Basic Information

    Device Name
    Looper (Model: ZX-579S)
    K Number
    K202055
    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
    Heat IN A Click, LLC
    Date Received
    July 24, 2020
    Decision Date
    April 16, 2021
    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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