510(k) · Cleared
ClearedMedical Diode Laser Systems (TR-B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baoding Te'Anzhou Electronic Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Nov 28, 2025 as substantially equivalent to K212734 (Triangel Rsd Limited, 2023) after a 98-day review. Its family tree reaches back 17 generations to 1995. 1 later device descends from it.
- Decided
- Nov 28, 2025
- Review
- 98 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K943450 (1995). 328 ancestors in all, the oldest K771218 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 2 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 1 generation backK212734 Diode laser therapy deviceTriangel Rsd Limited · 2023
- This deviceK252658 Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK262426 Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd. · 2026
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 backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 2 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 1 generation backK212734 Diode laser therapy deviceTriangel Rsd Limited · 2023
- This deviceK252658 Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd. · 2026 · cites it directly0descendants
View 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 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −2 | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| −1 | K212734 | Diode laser therapy device | Triangel Rsd Limited | 2023 | — |
| 0 (this device) | K252658 | Medical Diode Laser Systems (TR-B) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025 | — |
| +1 | K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 17 | 0 |
| 1995 | 16 | 0 |
| 1996 | 23 | 0 |
| 1997 | 27 | 0 |
| 1998 | 23 | 0 |
| 1999 | 19 | 0 |
| 2000 | 28 | 0 |
| 2001 | 29 | 0 |
| 2002 | 33 | 0 |
| 2003 | 28 | 0 |
| 2004 | 18 | 0 |
| 2005 | 11 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K212734 | Diode laser therapy deviceSummary page 6…I Panel: General & Plastic Surgery 4.0 Predicate device information 510(k) Summary K252658 Predicate device 510(k) Number: K212734 Product Name: Diode laser therapy device Manufacturer: Triangel Rsd Limited Reference device 1: 510(k) Num… | 2023 |
| † | K240179 | Medical Diode Laser (Model: L2) | 2024 |
| † | K082721 | Laserpro 810, 940 and 980 Diode Laser Systems | 2008 |
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 |
|---|---|---|---|
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | 2026 | 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 30 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 16 of the 328 ancestors have a recall of any class.
- Of its descendants, K262426 (Wuhan Pioon Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K212734.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device’s 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology…
Read the full statement (106 words)
The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device’s 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device’s 1470nm laser is intended for: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252658 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252658: Medical Diode Laser Systems (TR-B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252658
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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