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510(k) Data Aggregation

    K Number
    K032397
    Device Name
    DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
    Manufacturer
    Date Cleared
    2004-05-27

    (297 days)

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

    NORSELD PTY., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to: Treatment of wrinkles, Periocular wrinkles, Periorbital wrinkles. Facial and leg telangiectasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angioma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris, Verrucae/Warts, Scars. Striea, and Psoriasis. Podiatry - for benign cutaneous lesions and warts. The Dual Yellow lase, operating at 511 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutancous pigmented lesions including but not limited to: Lentigines, Solar keratoses. Adenoma serabaceum, Skin tabs, Trichoepitheliomas (benign lesions similar to skin tags) Naevi, Keratoses, Syringomas Seborrhoeic keratoses Verrucae vulgaris, and Warts.
    Device Description
    The Norseld Dual Yellow D10B Laser is a copper bromide laser which emits it energy at 511 and 578 nm. The device consists of an cabinet, fiber optic delivery system, and a user/software interface.
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    K Number
    K023899
    Device Name
    DUAL YELLOW LASER, MODEL D10B
    Manufacturer
    Date Cleared
    2003-02-20

    (90 days)

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

    NORSELD PTY., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dual Yellow Laser is intended for treatment of vascular and pigmented lesions.
    Device Description
    The Norseld Dual Yellow D10B Laser is a copper bromide laser which emits it energy at 511 and 578 nm. The device consists of an cabinet, fiber optic delivery system, and a user/software interface.
    Ask a Question

    Ask a specific question about this device

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