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This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.

The Microlux/DL is used to enhance dental examination of lesions of the oral mucosa. The device consists of a battery powered light source that uses a blue-white LED, a rigid diffused fiber optic light guide. It is used in conjunction with a non-toxic dilute (1%) acetic acid rinse for the viewing of oral lesions. The fiber optic illuminator itself is non-tissue contacting, and is classified as a 510(k) Exempt FDA Device.

The ViziLite Blue Oral Exam Product consists of the Vizilite and ViziLite Blue Oral Lesion Identification and Marking System. The Vizilite (OralLite) is a chemiluminescent light source system indicated for use as an adjunct to conventional oral mucosal screening by trained health care providers for the identification, evaluation, and monitoring of oral mucosal abnormalities in a population at increased risk for oral cancer. The ViziLite Blue Oral Lesion Identification and Marking-System, is a threecomponent swab system which is indicated as an adjunct to the ViziLite Test for oral mucosa lesions, for further evaluation and monitoring of lesions already differentially identified with Vizil ite in a population at increased risk for oral cancer The ViziLite Blue Oral Lesion Identification and Marking System is not being proposed for use in the initial oral mucosal examination without initial lesion identification with ViziLite. Furthermore, this ViziLite Blue Oral Lesion Identification and Marking System is not intended to be used as an indicator of lesions warranting further study, including biopsy. Whether a lesion is marked with the dye or not should not alter the clinician's clinical behavior as dictated by the results of the ViziLite examination. The marking dye, when positive, acts as a lesion marker that allows for the removal of the ViziLite device while preserving the anatomic character of the lesion.

ViziLite Blue Oral Exam Kit includes the ViziLite used as an adjunct to visual examination of the oral mucosa with incandescent light for identification of oral mucosal abnormalities and ViziLite Blue Oral Lesion Identification and Marking System to further assist with the evaluation and monitoring of ViziLiteldentified oral white mucosal abnormalities in patients at increased risk for oral cancer. The ViziLite-Blue™ Oral Exam Kit is a visualization system that is intended as an adjunct to conventional visual examination with incandescent light of oral mucosa and employs the same components and mechanism of action as the previously cleared ViziLite Test Kit (a.k.a. ViziLite Comprehensive Exam Tray K012070 and the OralLite Test Kit, K03995 and Acetic Acid Rinse) and is indicated for the same patient population and intended use. The ViziLite examination light source and accessories, including the 1% Acetic Acid Rinse, have not been changed nor significantly modified for production of the ViziLite-Blue Oral Exam Kit. The ViziLite Blue Oral Lesion Identification and Marking System, consists of three swab components, two swabs of 1% Acetic Acid Rinse, including a postdye decolorizer, and one swab with a metachromatic vital tissue dye, Tolonium chloride, also called Toluidine Blue. The application of the dye to ViziLite-Identified oral white mucosal lesions in a population at increased risk for oral cancer, during clinical trials was able to assist with evaluation, monitoring, and tissue sampling and helped physically mark and stain 51% of the ViziLite-Identified white lesions to allow the health care provider to visualize lesions with incandescent light.