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510(k) Data Aggregation

    K Number
    K100487
    Device Name
    EQUINOX CO2 LASER SYSTEM
    Manufacturer
    ECLIPSEMED GLOBAL, INC
    Date Cleared
    2010-11-29

    (283 days)

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

    ECLIPSEMED GLOBAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Equinox CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues. The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
    Device Description
    The Equinox CO2 laser has a wavelength of 10,600nm. CO2 fractional laser uses scanning optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments. This system consists of main body, color touch screen, Arm, hand-piece and Foot switch.
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    K Number
    K093465
    Device Name
    FUSION SYSTEM
    Manufacturer
    ECLIPSEMED GLOBAL, INC
    Date Cleared
    2010-01-05

    (60 days)

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

    ECLIPSEMED GLOBAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 500 – 1200nm intense pulsed light wavelengths are indicated for: - The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) - The treatment of cutaneous lesions, including warts, scars and striae The 560 – 1200nm intense pulsed light wavelengths are indicated for: - The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations The 600 - 1200nm intense pulsed light wavelengths are indicated for: - The removal of unwanted hair from all skin types and to effect stable, long-term or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The 400 - 1200nm intense pulsed light wavelengths are indicated for: - The treatment of moderate inflammatory acne vulgaris.
    Device Description
    The Fusion System consists of: The main console unit that incorporates the touch-screen control panel, power supply module, cooling system, switching module and isolation transformer Variety of handpieces Footswitch
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