# K033033: Vizilite-Blue Oral Exam Kit

- Pathway: 510(k) (Traditional)
- Applicant: Trylon Corp.
- Decided: Nov 22, 2004 after 423 days
- Product code: EAZ (Light, Operating, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003995 (2001). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012070: Orallite Comprehensive Exam Tray, Trylon Corp. (2001) Summary page 4.
- K003995: Speculite/Orallite, Trylon Corp. (2001) Summary page 6.

## Most influential descendants
- K082603: Trimira Ocs 3000 (2008), 8 descendants of its own
- K090135: Trimira Identafi 3000 (2009), 7 descendants of its own
- K101140: Dentlight Oral Exam Light Kit (2010), 5 descendants of its own
- K210550: VALO Grand Corded and Accessory Lenses (2021), 3 descendants of its own
- K220471: VALO X, VALO X Accessory Lenses (2022), 2 descendants of its own

## Indications for use
The VizilLite Blue Oral Exam Product consists of the Vizilite and Vizilite Blue Oral Lesion ldentification 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 ldentification and Marking-System, is a three-component swab system which is indicated as an adjunct to the ViziLite Test for oral mucosa lesions, for further evaluation and monitoring of lesions by providing physical marking of lesions already differentially identified with ViziLite 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 dentification 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 VizilLite device while preserving the anatomic character of the lesion.

Source page: https://510kreport.com/device/K033033
Methodology: https://510kreport.com/methodology