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After consideration of the public comments we received and our review of the application, we continue to believe that C1747 appropriately describes the LithoVue TM Elite Ureteroscope because C1747 includes any device that is a single-use (that is, disposable) endoscope with imaging/illumination capabilities intended for use in the urinary tract to perform ureteroscopy procedures

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Its ability to activate sirtuins, enhance DNA repair, regulate metabolism, influence fat cell metabolism in preclinical models and support mitochondrial health positions it as a compelling candidate for further investigation