BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    ELLIPSE I2PL+/ELLIPSE MULTIFLEX+

    K Number: K140670 · Decision Sep 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    7
    Review Days
    191

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    Basic Information

    Device Name
    ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
    K Number
    K140670
    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
    Ellipse A/S
    Date Received
    March 18, 2014
    Decision Date
    September 25, 2014
    Product Code
    ONF
    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
    ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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    Other Clearances by Ellipse A/S

    K Number Device Name
    K192951 Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
    K180406 Ellipse Ydun
    K161162 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
    K150907 Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
    K081408 ELLIPSE MULTIFLEX
    K072023 ELLIPSE JUVIA, MODEL 9EJU7465