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510(k) Data Aggregation

    K Number
    K073317
    Device Name
    STARLIGHT, MODEL PD9012
    Date Cleared
    2008-09-03

    (282 days)

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

    F.P. RUBINSTEIN Y CIA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    STARLIGHT® is a light-based system intended for the removal of unwanted hair (permanent hair reduction*) and the treatment of benign cutaneous, vascular and pigmentary lesions in skin phototypes I to V of the Fitzpatrick Table. *Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
    Device Description
    STARLIGHT® is a light-based system that delivers Intense Pulsed Light in the region of 530 to 1200 nanometers of the Electromagnetic Spectrum. The system has been designed to be compact and self-contained, comprising: -A central module -An LCD and soft-touch keyboard interface -Two application handpieces housing a flash lamp, a light conducting glass w/filter and two shooting buttons -An integrated Hydraulic Cooling System The system's electronics and user interface are controlled by a microcontroller.
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