In November of 2001 the U.S. Food and Drug Administration cleared ViziLite as an adjunctive screening technology for use in the oral cavity, thus making it the only FDA-cleared medical device for such an application. The technology to identify submucosal dysplastic tissue in non-keratinizing stratified squamous epithelium has been available since 1995.
Chemiluminescent light technology was originally tested on 13,000 cervical cancer patients and obtained FDA clearance for use as a visual screening device for cervical cancer. Clinical research demonstrated that the illumination device doubled cervical cancer detection. It is the same technology used in ViziLite.
In January of 2005 the U.S. Food and Drug Administration cleared the TBlue630 oral lesion marking system as an adjunctive technology for use with the ViziLite oral lesion identification system.
ViziLite Plus with TBlue630™ is the only FDA-cleared oral lesion identification and marking system available.