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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    GME ExSys 308

    K Number: K150752 · Decision Jul 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    2
    Review Days
    130

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    Basic Information

    Device Name
    GME ExSys 308
    K Number
    K150752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gme (German Medical Engineering) GmbH
    Date Received
    March 23, 2015
    Decision Date
    July 31, 2015
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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    Other Clearances by Gme (German Medical Engineering) GmbH

    K Number Device Name
    K141063 LINSCAN 808, LINSCAN 980