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A4. Biolux Light Emitting Diode Device Description Biolux LED device System Introduction Manufacturer Information Biolux Research Ltd. 825 Powell Street, Suite 220 Vancouver BC, Canada V6A 1H7 Toll Free: 888.669.0674 Tel: 604.669.0674 Fax: 604.608.5558 www.Bioluxresearch.com Device Identification Device Description The Biolux LED device is a low level LED phototherapy device intended to provide stimulation for accelerating orthodontic movement of teeth. The light is produced by Light Emitting Diodes which are small, efficient semiconductor devices used in many medical and dental applications. The Biolux LED device has a near infrared wavelength of 850 nm, very low level power (less than 50 mW/cm2), and a divergent beam. All light treatment is provided extra-orally, and, other than potentially accelerating the treatment time, at no point are the normal orthodontic treatments, procedures, or appliance altered or affected. Biolux has determined the Biolux LED device to be a Class 1M device in accordance with IEC 60825-1 “Safety – Part 1: Equipment classification, requirements and user’s guide”, and are therefore deemed “safe under reasonably foreseeable conditions.” No optics or magnifiers are employed with the beam. The United States Food and Drug Administration on August 18, 2010 advised us that our device and protocol is considered an NSR (Non significant risk). 77PDF Image | Effect of LED Phototherapy on the Rate of Orthodontic Tooth Movement
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