510(k) · Cleared

Recalled · Class II · 2013

SOLEA

K130420510(k) TraditionalCleared Jul 12, 2013143-day reviewClass II21 CFR 878.4810Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Convergent Dental, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jul 12, 2013 as substantially equivalent to K123494 (Convergent Dental, Inc., 2013) and 2 other predicates after a 143-day review. Its family tree reaches back 11 generations to 1992. 2 later devices descend from it. It has been recalled once.

Decided: Jul 12, 2013
Review: 143 days
Class: Class II
Product code: GEX
Recalls: 1
Predicates: 3

Its longest line of descent runs back 11 generations to K910422 (1992). 163 ancestors in all, the oldest K820106 (1982). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
7 generations between
3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
2 generations backK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
1 generation backK101817 Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2…Fotona D.D. · 2010
This deviceK130420 SOLEAConvergent Dental, Inc. · 2013
Descendant · cites it directly · 1 of its ownK151306 SoleaConvergent Dental, Inc. · 2015
Descendant · 2 generations on · 0 of its ownK221761 SoleaConvergent Dental, Inc. · 2022 · Recalled

Show all 11 generations

Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
5 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
4 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
2 generations backK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
1 generation backK101817 Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2…Fotona D.D. · 2010
This deviceK130420 SOLEAConvergent Dental, Inc. · 2013

Most influential descendants

Showing 2 of 2 · See all

K151306SoleaConvergent Dental, Inc. · 2015 · cites it directly1descendant
K221761SoleaConvergent Dental, Inc. · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K910422	Model RD-1200 Ruby Laser System	Spectrum Medical Technologies, Inc.	1992	—
−10	K961279	Sharplan Lasers, Inc. Ruby Laser System	Sharplan Lasers, Inc.	1996	—
−9	K962446	Sharplan Ruby Laser System	Sharplan Lasers, Inc.	1997	—
−8	K974536	Photoderm HR System	Esc Medical Systems, Ltd.	1998	—
−7	K991935	Epilight Hair Removal System, Photoderm HR System	Esc Medical Systems, Ltd.	2000	—
−6	K014040	Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…	Altus Medical, Inc.	2002	—
−5	K023193	Candela Gentle Yag Laser System	Candela Corp.	2002	—
−4	K033172	Candela Gentleyag Family of Laser Systems	Candela Corp.	2003	—
−3	K050293	Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag…	Fotona D.D.	2005	—
−2	K093162	Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at…	Fotona D.D.	2010	—
−1	K101817	Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2…	Fotona D.D.	2010	—
0 (this device)	K130420	SOLEA	Convergent Dental, Inc.	2013	—
+1	K151306	Solea	Convergent Dental, Inc.	2015	—
+2	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
2015	1	0
2022	1	0

FIG. 1 — Lineage of K130420, 1992–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K123494	SOLEA Summary page 2 …ditioal 510(k) Premarket Submission 6. Device Description The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494). The only changes from the previously cleared device are'the addition of the hard tissue indications, which combines minor softw…	Convergent Dental, Inc.	2013	1
*	K091746	Waterlase MD, Model 7100102 Summary page 2 …n terms of fluence, irradiance, measured comparative performance data, and all features that affect safety or effectiveness to the Biolase Technology, Inc. Waterlase MD (K091746) and the Fotona d.d., LightWalker Laser System (K101817). For soft tissue indications, the Solea system included herein is the sa…	Biolase Technology, Inc.	2009	—
*	K101817	Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E… Summary page 2 …formance data, and all features that affect safety or effectiveness to the Biolase Technology, Inc. Waterlase MD (K091746) and the Fotona d.d., LightWalker Laser System (K101817). For soft tissue indications, the Solea system included herein is the same device that was previously cleared by the FDA as the…	Fotona D.D.	2010	—

Also cleared against K123494: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K151306	Solea	Convergent Dental, Inc.	2015	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 12, 2013	Class II	Z-0050-2014	Software design	Specific error condition could lead to unintended laser emission during laser activation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
5 of the 163 ancestors have a recall of any class.
Of its descendants, K151306 (Convergent Dental, Inc., 2015) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K123494.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130420 · printed Nov 5, 2026

Cite this page

510(k) Report. “K130420: SOLEA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130420

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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