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

    ANTI-WRINKLE (AGING) LIGHT, MODEL AAL

    K Number: K092800 · Decision Feb 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    11
    Review Days
    146

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    Basic Information

    Device Name
    ANTI-WRINKLE (AGING) LIGHT, MODEL AAL
    K Number
    K092800
    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
    Led Intellectual Properties, LLC
    Date Received
    September 11, 2009
    Decision Date
    February 4, 2010
    Product Code
    ONE
    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
    ONE Powered Light Based Non-Laser Surgical Instrument

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