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

    LUX1540, LUX1440 & LUX2940 LASER HANDPIECES

    K Number: K101506 · Decision Sep 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    34
    Applicant Total
    24
    Review Days
    92

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    Basic Information

    Device Name
    LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
    K Number
    K101506
    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
    Palomar Medical Technologies, Inc.
    Date Received
    June 1, 2010
    Decision Date
    September 1, 2010
    Product Code
    ONG
    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
    ONG Powered Laser Surgical Instrument With MicrobeamFractional Output

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    Other Clearances by Palomar Medical Technologies, Inc.

    K Number Device Name
    K130250 QYAG LASER SYSTEM
    K120622 PALOMAR VECTUS LASER
    K110907 PALOMAR ICON (TM) AESTHETIC SYSTEM
    K103664 PRIMUS AESTHETIC PLATFORM
    K100270 ARTISAN AESTHETIC SYSTEM
    K090195 PALOMAR LUX1540 HANDPIECE
    K070298 MODIFICATION TO PALOMAR LUXIR HANDPIECE
    K063571 PALOMAR LUX2940 HANDPIECE
    K060839 ABC HAIR REMOVAL SYSTEM
    K061436 PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM
    Search all 24 clearances from Palomar Medical Technologies, Inc. →