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510(k) Data Aggregation

    K Number
    K143713
    Device Name
    Lustre PRO Light System
    Manufacturer
    AMBICARE HEALTH LTD
    Date Cleared
    2016-01-19

    (386 days)

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

    AMBICARE HEALTH LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lustre PRO light system is indicated for the treatment of mild to moderate acne.
    Device Description
    The Lustre PRO light system is a small portable non-invasive device, comprising of a rechargeable controller and therapy heads containing light emitting diodes, emitting blue light at a peak wavelength of 415nm, and a Full Width Half Maximum (FWHM) of 15nm. The therapy heads are designed to be attached to the site of the acne using a disposable polyethylene film impregnated with a medical-grade adhesive. The controller comprises of an LCD graphical user interface, 3 control buttons, a coaxial connector and 3 mini USB connectors. The controller switches the therapy heads on and off and includes a programmable timer, allowing modification of treatment time and indicators for battery level, therapy head status and treatment time remaining. The device contains sensors which monitor the therapy heads and emit audible and visible alarms relating to overheating and disconnection of the therapy heads.
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