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510(k) Data Aggregation

    K Number
    K123257
    Device Name
    EMVERA DIOLUX
    Manufacturer
    EMVERA TECHNOLOGIES, INC.
    Date Cleared
    2012-12-14

    (57 days)

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

    EMVERA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emvera Diolux is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen. Hair removal by laser or IPL sources can cause increase hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck. Caution: Federal (USA) law restricts this device for use by or on the order of a physician.
    Device Description
    This laser operation equipment is a diode laser of 808nm of pulsed diode laser. This equipment is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to be use in various treatments by effecting the skin by laser beam of 808nm. Diode laser of 808nm is able to transfer stable and uniform pulses to skin, therefore operator can treat patient safely and effectively using this equipment. This equipment provides direct visual color LCD screen configured with prompts for ease of use for the operator.
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