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510(k) Data Aggregation

    K Number
    K213332
    Device Name
    Multifrax Laser System
    Manufacturer
    Paradigm Medical Corporation
    Date Cleared
    2022-06-03

    (240 days)

    Product Code
    ONG
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Paradigm Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1550 nm: The Multifrax 1550 nm laser is indicated for use in dermatological procedures requiring coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1927 nm: The Multifrax 1927 mm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
    Device Description
    The Multifrax Laser System provides non-ablative fractional treatment using the 1550 nm and 1927 nm wavelengths. The mode of action is delivering a series of light pulses in a row as the handpiece tip is moved across the skin which leaves a pattern of microdots (Micro Thermal Zone (MTZ)) of irradiated skin. Multifrax Laser System is a dual-wavelength diode laser system comprising two laser sources emitting at 1550 and 1927 nm and generating fine pulses of energy. - Multifrax is a non-ablative and non-invasive fractional laser device. - Multifrax is a light portable laser combining a small laser unit and 2 long lasting rechargeable batteries equipped with a belt clip. - Multifrax offers optimized technical characteristics: adjustable treatment width, adjustable distance between laser pulses, distal tip with integrated high-performance movement and skin contact tracking sensors, and color touch screen display.
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