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510(k) Data Aggregation

    K Number
    K090639
    Device Name
    EXELO2, MODEL 4010
    Manufacturer
    QUANTEL DERMA GMBH
    Date Cleared
    2009-10-29

    (233 days)

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

    QUANTEL DERMA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.
    Device Description
    The EXELO2 is a CO2 laser device designed for dermatological use. It produces a coherent monochromatic radiation at the wavelength of 1.6 microns. The system is composed of a base which encloses the power supply and control interface, an articulated mirror arm, and a scanner handpiece.
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    K Number
    K090762
    Device Name
    LEDA
    Manufacturer
    QUANTEL DERMA GMBH
    Date Cleared
    2009-08-28

    (158 days)

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

    QUANTEL DERMA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LEDA System with the Applicator LEDA SCR 585 yellow is indicated for the treatment of periorbital wrinkles and rhytides. The LEDA System with the Applicator LEDA SCR 635 red is indicated for the treatment of superficial, benign vascular and pigmented lesions. The LEDA System with the Applicators LEDA EPI 808 and LEDA EPI 980 is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
    Device Description
    The system is composed of a table-top base unit that includes the power supply, software and cooling system. Different applicators containing the light sources can be plugged into the base unit. The device is controlled by a touch-screen graphic user interface. There are three kinds of applicators each of which is available with several wavelengths. For details see the following section. The LEDA is a device designed for dermatological use. Depending on the applicator selected wavelength in the range of 550-1,000 nm are produced either by Light Emitting Diodes (LED) or Diode Lasers. For each applicator and thus each wavelength there is a specific set of medical indications.
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