510(k) · Cleared
ClearedSolea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convergent Dental, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 23, 2015 as substantially equivalent to K123494 (Convergent Dental, Inc., 2013) and 3 other predicates after a 128-day review. Its family tree reaches back 12 generations to 1992. 1 later device descends from it.
- Decided
- Sep 23, 2015
- Review
- 128 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K910422 (1992). 164 ancestors in all, the oldest K820106 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
- 2 generations backK101817 Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2…Fotona D.D. · 2010
- 1 generation backK130420 SOLEAConvergent Dental, Inc. · 2013 · Recalled
- This deviceK151306 SoleaConvergent Dental, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK221761 SoleaConvergent Dental, Inc. · 2022 · Recalled
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 3 generations backK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
- 2 generations backK101817 Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2…Fotona D.D. · 2010
- 1 generation backK130420 SOLEAConvergent Dental, Inc. · 2013 · Recalled
- This deviceK151306 SoleaConvergent Dental, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K221761SoleaConvergent Dental, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −3 | K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at… | Fotona D.D. | 2010 | — |
| −2 | K101817 | Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2… | Fotona D.D. | 2010 | — |
| −1 | K130420 | SOLEA | Convergent Dental, Inc. | 2013 | 1 |
| 0 (this device) | K151306 | Solea | Convergent Dental, Inc. | 2015 | — |
| +1 | K221761 | Solea | Convergent Dental, Inc. | 2022 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K123494 | SOLEASummary page 4…Class II Classification Panel: General and Plastic Surgery 5. Legally Marketed Predicate Device(s) Convergent Dental, Inc., Solea, 510(k) Numbers: K123494, K130420 Biolase Technology, Inc., Waterlase MD, 510(k) Number: K091746 Fotona d.d., LightWalker Laser System, 510(k) Numbe… | 2013 |
| * | K130420 | SOLEASummary page 4…lass II Classification Panel: General and Plastic Surgery 5. Legally Marketed Predicate Device(s) Convergent Dental, Inc., Solea, 510(k) Numbers: K123494, K130420 Biolase Technology, Inc., Waterlase MD, 510(k) Number: K091746 Fotona d.d., LightWalker Laser System, 510(k) Number: K10181… | 2013 |
| * | K091746 | Waterlase MD, Model 7100102Summary page 4…y 5. Legally Marketed Predicate Device(s) Convergent Dental, Inc., Solea, 510(k) Numbers: K123494, K130420 Biolase Technology, Inc., Waterlase MD, 510(k) Number: K091746 Fotona d.d., LightWalker Laser System, 510(k) Number: K101817 6. Device Description… | 2009 |
| * | K101817 | Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Summary page 4…Inc., Solea, 510(k) Numbers: K123494, K130420 Biolase Technology, Inc., Waterlase MD, 510(k) Number: K091746 Fotona d.d., LightWalker Laser System, 510(k) Number: K101817 6. Device Description Page 5-1… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221761 | Solea | 2022 | 0 |
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 23 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 164 ancestors have a recall of any class.
- Of its descendants, K221761 (Convergent Dental, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123494.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Solea system is indicated for the following:
- Ablation of hard tissue for caries removal and cavity preparation
- Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity
- Cutting, shaving, contouring and resection of oral osseous tissue (bone)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151306: Solea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151306
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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