Nathaniel Group, a world leading provider of illumination systems used in micro-endoscopy, has announced that their Hyperion 200L and Hyperion 200LV medical illuminator products have been certified for use in the United States, Canada, and the European Union (EU). The Hyperion illumination systems allow access to areas of the anatomy previously inaccessible with conventional minimally invasive endoscopes. Both light sources offer full endoscopic illumination from a single fiber as small as 170 or 250um.
The Hyperion 200L Medical Illuminator and Hyperion 200LV Medical Illuminator with video processor were evaluated by independent companies to verify they met stringent standards for electromagnetic compliance, laser safety, usability, risk management, and other safety requirements.
'These new certifications for the Hyperion 200L and 200LV will help medical device manufacturers bring new products to market faster and at a lower regulatory cost.” said Joel Melnick, chief executive officer of Nathaniel Group, Inc. “OEMs can now integrate an Hyperion Medical Illuminator into their endoscopic or other medical system without undertaking additional testing to prove the laser illumination is safe for products designed for use in humans.”
Since achieving the CE mark, in addition to US and Canada certification, several Hyperion 200L and 200LV units have been purchased for evaluation and incorporated into human use applications by leading medical device manufacturers throughout the US and EU.
Testing for US and Canada certification was performed by Intertek Electrical Testing Laboratory (ETL). Testing for the European market and eligibility for the CE mark was performed by MT PRomedt Consulting GmbH.
