510(k) · Cleared
ClearedSol Portable Diode Laser Unit (with Wireless Foot Control)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regulatory Technology Services, LLC · GEX Powered Laser Surgical Instrument
Cleared on Jul 25, 2014 as substantially equivalent to K103667 (Den-Mat Holdings, LLC, 2010) and 1 other predicate after a 17-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jul 25, 2014
- Review
- 17 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K922901 (1992). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 5 generations between
- 3 generations backK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- 2 generations backK091796 Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC · 2009
- 1 generation backK102639 SL3Discus Dental, LLC · 2010 · Recalled
- This deviceK141838 Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC · 2014
Show all 9 generations
- Root · 9 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 8 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 7 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 6 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 5 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 4 generations backK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- 3 generations backK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- 2 generations backK091796 Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC · 2009
- 1 generation backK102639 SL3Discus Dental, LLC · 2010 · Recalled
- This deviceK141838 Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −8 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −7 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −6 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −5 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −4 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| −3 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| −2 | K091796 | Softlase Pro, Ortholase and Hygienelase | Zap Lasers, LLC | 2009 | — |
| −1 | K102639 | SL3 | Discus Dental, LLC | 2010 | 1 |
| 0 (this device) | K141838 | Sol Portable Diode Laser Unit (with Wireless Foot Control) | Regulatory Technology Services, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K103667 | Sapphire ST Portable Diode LaserSummary page 2…ional 5 10 (kc)Premarket Notification_ Company: Den-Mat Holdings, LLC Device: Sapphire ST Portable Diode Laser 510(k): K103667 Date Cleared: December 29, 20 10 Company: Discus Dental, LLC Device: SL3 510(k… | 2010 |
| * | K102639 | SL3Summary page 2…510(k): K103667 Date Cleared: December 29, 20 10 Company: Discus Dental, LLC Device: SL3 510(k): K102639 Date Cleared: December 0 1, 20 10 4. A description'of the device that is the subject of the 510(k), including an… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 28 ancestors have a recall of any class.
- 1 other device also cites its predicate K103667.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 SQL Portable Diode Laser Unit (with wireless foot control) is intended for use in dental intracoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; fnectomay; frenotomy; gingival incision and excision…
Read the full statement (96 words)
The SQL Portable Diode Laser Unit (with wireless foot control) is intended for use in dental intracoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; fnectomay; frenotomy; gingival incision and excision; gingivectomy; gingivoplast; incising and draining abscesses; opercuiectomy; oral papillectoiny; removal of fibromas; soft tissue crown lengthening; suilcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibulopiasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141838: Sol Portable Diode Laser Unit (with Wireless Foot Control).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141838
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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