US Customs Ruling (CROSS)
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Ruling Number :
Issuing Country : UNITED STATES
Date Of Issue : 2021-07-08T00:00:00
VELscope®Vx system, a natural tissue florescence direct visualization system
The merchandise under consideration is the VELscope® Vx system, a natural tissue florescence direct visualization system designed to be used as an adjunctive instrument for oral mucosal examination. The main components of the system are (1) a viewing Handpiece (wireless handheld scope) which incorporates a light source, viewing optics including filters, a rechargeable battery, a power button, and other components, (2) a charging cradle, and (3) an external power supply (power brick). You state that the VELscope®Vx Handpiece emits a safe, visible blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce allowing the oral cavity to be examined in real time, enhancing the practitioner’s ability to quickly identify suspicious tissue that may require further investigation. When viewed through the Handpiece, abnormal tissue typically appears as an irregular, dark area that stands out against the otherwise normal, green fluorescence pattern of surrounding healthy tissue. The system is further intended to be used by an oral surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
Description : VELscope®Vx system
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Source : US Customs Ruling (CROSS)
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