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

    EQUINOX CO2 LASER

    K Number: K131903 · Decision Sep 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    EQUINOX CO2 LASER
    K Number
    K131903
    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
    Eclipse Aesthetics, LLC
    Date Received
    June 25, 2013
    Decision Date
    September 19, 2013
    Product Code
    ONG
    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
    ONG Powered Laser Surgical Instrument With MicrobeamFractional Output

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    Other Clearances by Eclipse Aesthetics, LLC

    K Number Device Name
    K122922 E-BEAM ND: YAG LASER