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510(k) Data Aggregation

    K Number
    K090724
    Device Name
    OR-LIGHT
    Manufacturer
    Date Cleared
    2009-10-07

    (202 days)

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

    YPERION TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Or-Light® is a non-coherent light-based device intended to carry out dermatologic and aesthetic care. It is meant to be handled by competent professionals trained in intense pulsed light technology. Two different applicators can be used on the Or-Light® device. The HR applicator (610-1000 nm) is indicated for: - Hair Removal for skintype I to IV The SR applicator (400-1000 nm) is indicated for - Benign pigmentary lesions for skintype I to III - Benign vascular lesions for skintype I to III - Inflammatory acne treatment for skintype I to III
    Device Description
    The Or-Light® is a non-coherent light based device intended to carry out dermatologic and aesthetic care on patients by skin professional. The system consists of a console containing a power unit controlled by electronic and software. Setting is selected by the operator through a display panel (touch screen). Light energy for the treatment is generated by the applicators connected to the device. Two type of applicator can be connected, one at a time. The applicators are in the waveband of 400 nm - 1000 nm and 610 nm - 1000 nm. The applicator is cooled by a closed water cooling circuit built in the device.
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