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510(k) Data Aggregation

    K Number
    K060234
    Device Name
    MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
    Manufacturer
    MCCUE PLC
    Date Cleared
    2006-03-15

    (44 days)

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

    MCCUE PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The McCue Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions. - . Intense Pulsed Light Energy / wavelengths (530 - 950nm) The 530 - 950nm intense pulsed wavelengths are indicated for: The treatment of mild to moderate inflammatory Acne Vulgaris. The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations. - . Intense Pulsed Light Energy / wavelengths (610 - 950nm) The 610 - 950nm intense pulsed wavelengths are indicated for: The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles. 11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
    Device Description
    The McCUE Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system is designed to be compact and self contained and includes the following features: - . Control console unit - Display panel . - Power supply . - Cooling system . - Removable handpiece with integrated switch, lamp, filter and glass coupling . block
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    K Number
    K040659
    Device Name
    MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
    Manufacturer
    MCCUE PLC
    Date Cleared
    2004-06-01

    (81 days)

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

    MCCUE PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The McCue Energist ULTRATM VPL Intense Pulsed Light System is intended for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions. - Intense Pulsed light Energy / wavelengths (530 950nm) . The 530-950nm intense pulsed wavelengths are indicated for : The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae. The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations. - Intense Pulsed light Energy / wavelengths (610 950nm) . The 610-950nm intense pulsed 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. 11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
    Device Description
    The McCue Energist ULTRA™ is a light-based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system has been designed to be compact and self-contained that includes: Control console unit Display panel Power supply Cooling system Removable handpiece with integrated switch, lamp, filter and glass coupling block
    Ask a Question

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