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

    UltraLase Flexible CO2 Laser Waveguide

    K Number: K211761 · Decision Jul 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    1
    Review Days
    52

    Basic Information

    Device Name
    UltraLase Flexible CO2 Laser Waveguide
    K Number
    K211761
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W & R Investments, LLC dba Laser Engineering
    Date Received
    June 8, 2021
    Decision Date
    July 30, 2021
    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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