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510(k) Data Aggregation

    K Number
    K141986
    Device Name
    ELUX 810 LASER
    Date Cleared
    2015-01-30

    (192 days)

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

    EQUIPMED NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ELux810 Laser is indicated for hair removal, permanent hair reduction in people with Fitzpatrick skin type I-V. It is also indicated for the treatment of benign superficial vascular and benign superficial pigmented lesions in people with Fitzpatrick skin type I-IV. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
    Device Description
    The ELux810 Laser is a diode laser of 808nm system. This device is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to use in various treatments by effecting to skin by laser beam of 808nm generated from laser diode. Diode laser of CW system is able to transfer stable and uniform pulses to skin, therefore medical doctor can treat patient safely and effectively using this equipment.
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