510(k) · Cleared
Recalled · Class II · 2023Solea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convergent Dental, Inc. · NVK Laser, Dental, Soft Tissue
Cleared on Sep 14, 2022 as substantially equivalent to K151306 (Convergent Dental, Inc., 2015) after an 89-day review. Its family tree reaches back 13 generations to 1992. It has been recalled once.
- Decided
- Sep 14, 2022
- Review
- 89 days
- Class
- Class II
- Product code
- NVK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 13 generations to K910422 (1992). 165 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations between
- 3 generations backK101817 Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2…Fotona D.D. · 2010
- 2 generations backK130420 SOLEAConvergent Dental, Inc. · 2013 · Recalled
- 1 generation backK151306 SoleaConvergent Dental, Inc. · 2015
- This deviceK221761 SoleaConvergent Dental, Inc. · 2022
Show all 13 generations
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 11 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 10 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 9 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 8 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 7 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 6 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 5 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 4 generations backK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
- 3 generations backK101817 Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2…Fotona D.D. · 2010
- 2 generations backK130420 SOLEAConvergent Dental, Inc. · 2013 · Recalled
- 1 generation backK151306 SoleaConvergent Dental, Inc. · 2015
- This deviceK221761 SoleaConvergent Dental, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −12 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −10 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −9 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −8 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −7 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −6 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −5 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −4 | K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at… | Fotona D.D. | 2010 | — |
| −3 | K101817 | Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2… | Fotona D.D. | 2010 | — |
| −2 | K130420 | SOLEA | Convergent Dental, Inc. | 2013 | 1 |
| −1 | K151306 | Solea | Convergent Dental, Inc. | 2015 | — |
| 0 (this device) | K221761 | Solea | Convergent Dental, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 6 | 0 |
| 1994 | 14 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 14 | 0 |
| 1998 | 14 | 0 |
| 1999 | 10 | 0 |
| 2000 | 12 | 0 |
| 2001 | 12 | 0 |
| 2002 | 18 | 0 |
| 2003 | 7 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 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 NVK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NVK device
- #1 K210367 D-Laser Blue, D-Laser 16score 20.7 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K151306 | SoleaSummary page 4…trument for use in general and plastic surgery and dermatology; 21 C.F.R. §878.4810 Class II Product Code: GEX Predicate Device Convergent Dental, Inc. Solea cleared in K151306 (Primary Predicate) Device Description The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser e… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 1, 2023 | Class II | Z-0324-2024 | Under Investigation by firm | It has been found that potential unintended laser activation can occur without foot pedal depression. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 165 ancestors have a recall of any class.
How does its category compare?
All NVK devicesNVK Laser, Dental, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NVK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVK
139in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NVK
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVK
1in 2024
MAUDE reports naming product code NVK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 4 | 277 | 0 | 0 |
| 2022 | 5 | 139 | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Solea system is indicated for the following:
• Ablation of hard tissue for caries removal and cavity prevention
• Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity
• Cutting, shaving, contouring and resection of oral osseous tissue (both)
• Aiding in the reduction of mineral loss in dental enamel
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221761: Solea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221761
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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