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510(k) Data Aggregation

    K Number
    K070063
    Device Name
    YAG MIR II LASER
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2007-01-30

    (25 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    1064nm: The Cynosure YAG MIR II laser is intended for the coagulation and hemostasis of benign vascular lesions, such as , but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

    The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

    1320mm: The Cynosure YAG MIR II laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of perioral and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.

    1440nm: The Cynosure YAG MIR II laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles and pigmented lesions.

    Device Description

    The Cynosure Y AG MIR II laser is a Nd: Y AG laser, having a ND:YAG crystal rod as a lasing medium. Laser activation is by footswitch or finger switch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.

    AI/ML Overview

    The provided 510(k) summary for the Cynosure YAG MIR II Laser does not include any acceptance criteria or a study proving the device meets them.

    Instead, the summary states:

    • Nonclinical Performance Data: none
    • Clinical Performance Data: none

    This indicates that the device's substantial equivalence to predicate devices was based on its similarity in intended use, principle of operation, and technical specifications (wavelengths and pulse energy range), rather than new performance data or clinical studies.

    Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving the device meets them from the provided text.

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