# K070523: Modification to: Velscope

- Pathway: 510(k) (Traditional)
- Applicant: Led Dental, Inc.
- Decided: Apr 5, 2007 after 41 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: 2 generations back to K003995 (2001). 2 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060920: Velscope, Led Medical Diagnostics, Inc. (2006) Summary page 1.

## 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
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 that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. VELscope 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/K070523
Methodology: https://510kreport.com/methodology