BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    I-LIPO SYSTEM

    K Number: K111501 · Decision Mar 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    297

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    Basic Information

    Device Name
    I-LIPO SYSTEM
    K Number
    K111501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chromogenex Technologies Limited
    Date Received
    May 31, 2011
    Decision Date
    March 23, 2012
    Product Code
    OLI
    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
    OLI Fat Reducing Low Level Laser

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    Other Clearances by Chromogenex Technologies Limited

    K Number Device Name
    K081619 CHROMOLITE EP