# K102083: Velscope VX

- Pathway: 510(k) (Traditional)
- Applicant: Led Dental, Inc.
- Decided: Nov 18, 2010 after 115 days
- Product code: NXV (Diagnostic Light, Soft Tissue Detector)
- Device class: 2
- Regulation: 21 CFR 872.6350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003995 (2001). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070523: Modification to: Velscope, Led Dental, Inc. (2007) Summary page 1.

## Most influential descendants
- K151630: G.o.c.c.l.e.s. (2015), 0 descendants of its own
- K123169: Oralid (2013), 0 descendants of its own

## Indications for use
VELscope Vx is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia. VELscope Vx is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

Source page: https://510kreport.com/device/K102083
Methodology: https://510kreport.com/methodology