# K060920: Velscope

- Pathway: 510(k) (Traditional)
- Applicant: Led Medical Diagnostics, Inc.
- Decided: Apr 27, 2006 after 23 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: 1 generation back to K003995 (2001). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003995: Speculite/Orallite, Trylon Corp. (2001) Summary page 1.

## Most influential descendants
- K070523: Modification to: Velscope (2007), 10 descendants of its own
- 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

## Indications for use
VELscope 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.

Source page: https://510kreport.com/device/K060920
Methodology: https://510kreport.com/methodology