510(k) · Cleared
ClearedPioneer Elite Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CAO Group, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 13, 2013 as substantially equivalent to K062258 (Ivoclar Vivadent, Inc., 2007) and 2 other predicates after a 150-day review. Its family tree reaches back 17 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 13, 2013
- Review
- 150 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K943450 (1995). 206 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK082938 EzlaseBiolase Technology, Inc. · 2008
- This deviceK131059 Pioneer Elite Diode LaserCAO Group, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK181602 Pioneer Elite Diode LaserCAO Group, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK142225 Pilot Elite Diode LaserCAO Group, Inc. · 2014
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK082938 EzlaseBiolase Technology, Inc. · 2008
- This deviceK131059 Pioneer Elite Diode LaserCAO Group, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −4 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −3 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −1 | K082938 | Ezlase | Biolase Technology, Inc. | 2008 | — |
| 0 (this device) | K131059 | Pioneer Elite Diode Laser | CAO Group, Inc. | 2013 | — |
| +1 | K181602 | Pioneer Elite Diode Laser | CAO Group, Inc. | 2019 | — |
| +1 | K142225 | Pilot Elite Diode Laser | CAO Group, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 23 | 0 |
| 1998 | 13 | 0 |
| 1999 | 10 | 0 |
| 2000 | 15 | 0 |
| 2001 | 16 | 0 |
| 2002 | 19 | 0 |
| 2003 | 13 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 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? (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 | Decided |
|---|---|---|---|
| * | K062258 | Genesis Diode LaserSummary page 1…ered Laser Surgical Instrument Legally Marketed Predicate Devices for Substantial Equivalence: Odyssey Navigator Diode Laser, manufactured for Ivoclar Vivadent, Inc. (K062258) Pilot Diode Laser, manufactured by CAO Grou, Inc. (K 100 143) ezLase. manufactured by Biolase. Inc. (K082938) Rationale for… | 2007 |
| * | K100143 | Pilot Diode Laser, Model 002-00139Summary page 1…evices for Substantial Equivalence: Odyssey Navigator Diode Laser, manufactured for Ivoclar Vivadent, Inc. (K062258) Pilot Diode Laser, manufactured by CAO Grou, Inc. (K 100 143) ezLase. manufactured by Biolase. Inc. (K082938) Rationale for Substantial Equivalence: The present device shares similar spec… | 2010 |
| * | K082938 | EzlaseSummary page 1…tor Diode Laser, manufactured for Ivoclar Vivadent, Inc. (K062258) Pilot Diode Laser, manufactured by CAO Grou, Inc. (K 100 143) ezLase. manufactured by Biolase. Inc. (K082938) Rationale for Substantial Equivalence: The present device shares similar specific indications with the aforementioned devices… | 2008 |
What descends from it? (2)
2 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 18 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 8 of the 206 ancestors have a recall of any class.
- Of its descendants, K181602 (CAO Group, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K062258.
How does its category compare?
All GEX devicesGEX 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
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 Pioneer Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, firenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue. 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis…
Read the full statement (98 words)
The Pioneer Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of:
1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, firenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue.
2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131059: Pioneer Elite Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131059
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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