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

    XTRAC XL, MODEL AL8000

    K Number: K041943 · Decision Oct 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    10
    Review Days
    87

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    Basic Information

    Device Name
    XTRAC XL, MODEL AL8000
    K Number
    K041943
    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
    Photo Medex, Inc.
    Date Received
    July 19, 2004
    Decision Date
    October 14, 2004
    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 Photo Medex, Inc.

    K Number Device Name
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    K040294 LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980
    K040234 LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
    K031451 XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
    K020847 XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
    K011382 XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
    K003705 XTRAC EXCIMER LASER SYSTEM, MODEL AL7000