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

    PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS

    K Number: K013365 · Decision Jan 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
    K Number
    K013365
    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
    Medical Bio Care Sweden AB
    Date Received
    October 10, 2001
    Decision Date
    January 8, 2002
    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 Medical Bio Care Sweden AB

    K Number Device Name
    K023081 PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
    K022378 PLASMALITE PULSED LIGHT SYSTEM
    K022569 PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
    K022568 PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
    K013366 PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
    K010927 MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
    K010928 PROLITE VL PULSED LIGHT SYSTEM
    K000929 PROLITE PULSED LIGHT SYSTEM
    K002072 PROLITE VL PULSED LIGHT SYSTEM