510(k) · Cleared
ClearedModification to: Velscope
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 Apr 5, 2007 as substantially equivalent to K060920 (Led Medical Diagnostics, Inc., 2006) after a 41-day review. Its family tree reaches back 2 generations to 2001. 10 later devices descend from it.
- Decided
- Apr 5, 2007
- Review
- 41 days
- Class
- Class II
- Product code
- NXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003995 (2001). 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK003995 Speculite/OralliteTrylon Corp. · 2001
- 1 generation backK060920 VelscopeLed Medical Diagnostics, Inc. · 2006
- This deviceK070523 Modification to: VelscopeLed Dental, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK082603 Trimira Ocs 3000Remicalm, LLC · 2008
- Descendant · 2 generations on · 7 of its ownK090135 Trimira Identafi 3000Remicalm, LLC · 2009
- Descendant · cites it directly · 5 of its ownK101140 Dentlight Oral Exam Light KitDentlight, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK210550 VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK220471 VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K082603Trimira Ocs 3000Remicalm, LLC · 2008 · cites it directly8descendants
- K090135Trimira Identafi 3000Remicalm, LLC · 2009 · 2 generations on7descendants
- K101140Dentlight Oral Exam Light KitDentlight, Inc. · 2010 · cites it directly5descendants
- K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021 · 2 generations on3descendants
- K220471VALO X, VALO X Accessory LensesUltradent Products, Inc. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| −1 | K060920 | Velscope | Led Medical Diagnostics, Inc. | 2006 | — |
| 0 (this device) | K070523 | Modification to: Velscope | Led Dental, Inc. | 2007 | — |
| +1 | K082603 | Trimira Ocs 3000 | Remicalm, LLC | 2008 | — |
| +2 | K090135 | Trimira Identafi 3000 | Remicalm, LLC | 2009 | — |
| +1 | K101140 | Dentlight Oral Exam Light Kit | Dentlight, Inc. | 2010 | — |
| +2 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021 | — |
| +3 | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K060920 | VelscopeSummary page 1…: (604) 541-4613 Device Name: VELscope Common Name: Oral Examination Light Classification Name: Ultraviolet detector Marketed Device of Equivalence: VELscope (K060920) Description of Device: VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool f… | 2006 |
What descends from it? (10)
3 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 6 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082603 (Remicalm, LLC, 2008) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K060920.
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. 2007, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070523: Modification to: Velscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070523
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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