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

    VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9

    K Number: K000158 · Decision Aug 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    4
    Review Days
    218

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    Basic Information

    Device Name
    VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
    K Number
    K000158
    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
    Fisma, Inc.
    Date Received
    January 19, 2000
    Decision Date
    August 24, 2000
    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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    Other Clearances by Fisma, Inc.

    K Number Device Name
    K991464 DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50
    K990174 ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV
    K963124 PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)