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510(k) Data Aggregation
K Number
K053364Device Name
HALUX IRIS EXAMINATION AND SURGICAL LAMP
Manufacturer
WALDMANN LIGHTING
Date Cleared
2006-02-23
(83 days)
Product Code
FTD
Regulation Number
878.4580Why 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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