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510(k) Data Aggregation

    K Number
    K053364
    Device Name
    HALUX IRIS EXAMINATION AND SURGICAL LAMP
    Manufacturer
    WALDMANN LIGHTING
    Date Cleared
    2006-02-23

    (83 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    WALDMANN LIGHTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.
    Device Description
    Whether in the doctor's office, examination rooms, emergency facilities, intensive care clinics, pre- or post-operative rooms, the Iris provides high intensity light where it is needed. The Iris is user friendly. With its high quality illumination, the halux® Iris is perfect for lighting all kinds of examinations and treatments. Outstanding features of this luminaire include the unique shape of the lamp housing, the combination facetted and parabolic technology of its reflector, and its smooth operating and spring-loaded articulating arm. Highlights of our examination lamp: Smooth Operation and adjustability Precise positioning Compact and enclosed articulation system with counterbalance system. A specially designed reflector system insures a precise light source that renders true colors. The Iris is available in ceiling wall and floor versions. halux® Iris is a medical product manufactured in accordance with EG 93/42 Class 1 and is constructed in accordance with EN 60 601-2-41 (UL2601).
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