510(k) · Cleared
ClearedVelscope VX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Led Dental, Inc. · NXV Diagnostic Light, Soft Tissue Detector
Cleared on Nov 18, 2010 as substantially equivalent to K070523 (Led Dental, Inc., 2007) after a 115-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Nov 18, 2010
- Review
- 115 days
- Class
- Class II
- Product code
- NXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003995 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK003995 Speculite/OralliteTrylon Corp. · 2001
- 2 generations backK060920 VelscopeLed Medical Diagnostics, Inc. · 2006
- 1 generation backK070523 Modification to: VelscopeLed Dental, Inc. · 2007
- This deviceK102083 Velscope VXLed Dental, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK151630 G.o.c.c.l.e.s.Pierrel Pharma S.R.L. · 2015
- Descendant · cites it directly · 0 of its ownK123169 OralidForward Science, LLC · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| −2 | K060920 | Velscope | Led Medical Diagnostics, Inc. | 2006 | — |
| −1 | K070523 | Modification to: Velscope | Led Dental, Inc. | 2007 | — |
| 0 (this device) | K102083 | Velscope VX | Led Dental, Inc. | 2010 | — |
| +1 | K151630 | G.o.c.c.l.e.s. | Pierrel Pharma S.R.L. | 2015 | — |
| +1 | K123169 | Oralid | Forward Science, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NXV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070523 | Modification to: VelscopeSummary page 1…(604) 434-4612 Device Name: VELscope Vx Common Name: Oral Examination Light Classification Name: Ultraviolet detector Marketed Device of Equivalence: VELscope (K070523) Description of Device: The VELscope Vx system is a natural tissue fluorescence direct visualization system to be used as an ad… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K151630 (Pierrel Pharma S.R.L., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K070523.
How does its category compare?
All NXV devicesNXV Diagnostic Light, Soft Tissue Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NXV
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NXV
95in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXV
No recall names NXV since 2007.
Adverse event reports per year · NXV
1in 2018
MAUDE reports naming product code NXV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 95 | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102083: Velscope VX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102083
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026