510(k) · Cleared
ClearedPilot Diode Laser, Model 002-00139
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 Aug 13, 2010 as substantially equivalent to K063396 (Lasering S.R.L., 2007) and 2 other predicates after a 206-day review. Its family tree reaches back 15 generations to 1995. 20 later devices descend from it.
- Decided
- Aug 13, 2010
- Review
- 206 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K943450 (1995). 185 ancestors in all, the oldest K800617 (1980). 20 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 2 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 1 generation backK063396 Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
- This deviceK100143 Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK123443 Precise SHP Diode LaserCAO Group, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- Descendant · 2 generations on · 3 of its ownK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK200693 K2 MobileHulaser, Inc. · 2020
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 2 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 1 generation backK063396 Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
- This deviceK100143 Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K123443Precise SHP Diode LaserCAO Group, Inc. · 2013 · cites it directly9descendants
- K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013 · cites it directly6descendants
- K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016 · 2 generations on3descendants
- K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015 · 2 generations on3descendants
- K200693K2 MobileHulaser, Inc. · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −1 | K063396 | Velure Family of Diode Lasers and Delivery Device Accessories | Lasering S.R.L. | 2007 | — |
| 0 (this device) | K100143 | Pilot Diode Laser, Model 002-00139 | CAO Group, Inc. | 2010 | — |
| +1 | K123443 | Precise SHP Diode Laser | CAO Group, Inc. | 2013 | — |
| +1 | K122567 | Joule 810/940/980 Multi-Platform System | Sciton, Inc | 2013 | — |
| +2 | K162114 | Photon, Photon Plus | Zolar Technology & Mfg Co., Inc. | 2016 | — |
| +2 | K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015 | — |
| +3 | K200693 | K2 Mobile | Hulaser, Inc. | 2020 | — |
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 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 13 | 0 |
| 1996 | 15 | 0 |
| 1997 | 20 | 0 |
| 1998 | 11 | 0 |
| 1999 | 8 | 0 |
| 2000 | 15 | 0 |
| 2001 | 14 | 0 |
| 2002 | 19 | 0 |
| 2003 | 13 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K063396 | Velure Family of Diode Lasers and Delivery Device AccessoriesSummary page 1…Powered Laser Surgical Instrument Legally Marketed Predicate Devices for Substantial Equivalence: Velure Family of Diode Lasers, manufaictured by Laserine S.R.L. (K063396) DenLaser 800 Plus, manufactured by CAO Group. Inc. (K062619) THOR VR Single Diode Laser Treatmnent Probe, manufactured by Thor… | 2007 |
| * | K062619 | Denlaser 800 PlusSummary page 1…cate Devices for Substantial Equivalence: Velure Family of Diode Lasers, manufaictured by Laserine S.R.L. (K063396) DenLaser 800 Plus, manufactured by CAO Group. Inc. (K062619) THOR VR Single Diode Laser Treatmnent Probe, manufactured by Thor International (K070024) Rationale for Substantial Equivale… | 2006 |
| * | K070024 | Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode ProbeSummary page 1…serine S.R.L. (K063396) DenLaser 800 Plus, manufactured by CAO Group. Inc. (K062619) THOR VR Single Diode Laser Treatmnent Probe, manufactured by Thor International (K070024) Rationale for Substantial Equivalence: The aforementioned laser devices and their accompanying delivery systems share s… | 2007 |
What descends from it? (20)
See all 203 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 15 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 7 of the 185 ancestors have a recall of any class.
- Of its descendants, K123443 (CAO Group, Inc., 2013) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K063396.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Pilot Diode Laser is indicated for the procedures of
1) Removal of lesions, excision, incision, vaporization, ablation, hemostasis,
and photocoagulation on soft tissue in the medical fields of
otolaryngology (ear, nose, and throat), dentistry and oral surgery,
arthroscopy, gastroenterology, dermatology, podiatry, general surgery,
urology, gynecology, and plastic surgery.
And
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100143: Pilot Diode Laser, Model 002-00139.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100143
Report an extraction error
Are you the manufacturer?
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