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

    Gemini 810+980 Soft Tissue Laser

    K Number: K192617 · Decision Feb 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    2
    Review Days
    150

    Basic Information

    Device Name
    Gemini 810+980 Soft Tissue Laser
    K Number
    K192617
    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
    Azena Medical, LLC
    Date Received
    September 23, 2019
    Decision Date
    February 20, 2020
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Azena Medical, LLC

    K Number Device Name
    K210350 Gemini 2 810+980 Soft Tissue Laser