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510(k) Data Aggregation

    K Number
    K132286
    Device Name
    HYPERION LONG PULSED ND: YAG LASER
    Manufacturer
    SCARLET RF, INC
    Date Cleared
    2014-01-22

    (183 days)

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

    SCARLET RF, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hyperion is a long pulsed Nd:YAG laser intended for treatment of wrinkles, Removal of unwanted hair for stable long term or *permanent hair reduction, treatment of pseudofolliculitis barbae (PFB), surgical incision, excision, vaporization, ablation and coagulation of soft tissue, and photocoagulation and hemostasis of pigmented and vascular lesions in dermatology. *Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-grown when measured at 6, 9, and 12 months after the completion of a treatment regimen
    Device Description
    Hyperion is a long pulse Nd:YAG laser system that produces laser emission at the wavelength of 1064nm. The system consists of three interconnected sections: a) the main cabinet, which houses the power supply, cooling system, microprocessor, and the laser generator, b) the optical fiber with hand pieces which can be used selectively depending on the size of the laser beam exposure, c) the footswitch.
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