The VELscope Vx enhanced oral assessment system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is now available for sale in the U.S., LED Dental announced.
The first-generation VELscope device was introduced in 2006 and, since then, LED Dental has sold almost 6,000 devices. These devices have been used to conduct almost 10 million enhanced oral soft-tissue exams worldwide, the company noted.
"We are extremely excited about the potential of the VELscope Vx system to significantly increase the number of dental practices conducting comprehensive screenings for oral cancer and other forms of oral disease," said Peter Whitehead, founder and CEO of LED Dental, in a press release. "The device's portability makes it easy to transport between operatories within the dental practice, and its attractive pricing makes it possible for practices to charge very low exam fees to their patients."
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