510(k) · Cleared
ClearedMedical Diode Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Gigaa Optronics Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Dec 23, 2015 as substantially equivalent to K082721 (Photo Medex, Inc., 2008) and 2 other predicates after a 166-day review. Its family tree reaches back 20 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 23, 2015
- Review
- 166 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K943450 (1995). 454 ancestors in all, the oldest K771218 (1978). 3 later devices descend from it, 3 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- 2 generations backK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- 1 generation backK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- This deviceK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK191349 980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK173067 LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC · 2018
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 7 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 6 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- 3 generations backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- 2 generations backK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- 1 generation backK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- This deviceK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd. · 2025 · cites it directly0descendants
- K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019 · cites it directly0descendants
- K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −7 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −6 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810 | A.R.C Laser GmbH | 2008 | — |
| −3 | K091562 | Doctor Smile a-810 and B-980 Lasers | Lambda Scientific Spa | 2009 | — |
| −2 | K102036 | Doctor Surgery Diode Lasers Family | Lambda S.P.A. | 2010 | — |
| −1 | K122567 | Joule 810/940/980 Multi-Platform System | Sciton, Inc | 2013 | — |
| 0 (this device) | K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015 | — |
| +1 | K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems… | Wuhan Dimed Laser Technology Co., Ltd. | 2025 | — |
| +1 | K191349 | 980nm Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | 2019 | — |
| +1 | K173067 | LightForce LTS Model 1000, 1500, 2500, and 4000 | Litecure, LLC | 2018 | — |
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 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 7 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 19 | 0 |
| 1995 | 18 | 0 |
| 1996 | 25 | 0 |
| 1997 | 30 | 0 |
| 1998 | 28 | 0 |
| 1999 | 24 | 0 |
| 2000 | 34 | 0 |
| 2001 | 34 | 0 |
| 2002 | 42 | 0 |
| 2003 | 41 | 0 |
| 2004 | 28 | 0 |
| 2005 | 22 | 0 |
| 2006 | 13 | 0 |
| 2007 | 13 | 0 |
| 2008 | 14 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K082721 | Laserpro 810, 940 and 980 Diode Laser SystemsSummary page 5…-15A/15B, VELASⅡ-30A/30B, VELASⅡ-60A/60B/60C Classification Panel: General & Plastic Surgery Product Code: GEX Device Classification: Class II 4. The Predicate Devices K082721 LaserPro Diode Surgical Laser System, LaserPro 810, LaserPro 980 K122567 JOULE 810/940/980 Multi-Platform System, JOULE 810, JOUL… | 2008 |
| * | K122567 | Joule 810/940/980 Multi-Platform SystemSummary page 5…l & Plastic Surgery Product Code: GEX Device Classification: Class II 4. The Predicate Devices K082721 LaserPro Diode Surgical Laser System, LaserPro 810, LaserPro 980 K122567 JOULE 810/940/980 Multi-Platform System, JOULE 810, JOULE 940, JOULE 980 K100558 Quanta System QUANTA Diode Laser Family, QUANTA… | 2013 |
| * | K100558 | Quanta Diode Laser SystemSummary page 5…dicate Devices K082721 LaserPro Diode Surgical Laser System, LaserPro 810, LaserPro 980 K122567 JOULE 810/940/980 Multi-Platform System, JOULE 810, JOULE 940, JOULE 980 K100558 Quanta System QUANTA Diode Laser Family, QUANTA 808, QUANTA 980 5. Device Description Medical diode laser systems are a kind of… | 2010 |
What descends from it? (3)
3 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 20 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 21 of the 454 ancestors have a recall of any class.
- Of its descendants, K252063 (Wuhan Dimed Laser Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K082721.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 "“GBOX-15A/15B" are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser…
Read the full statement (179 words)
The "“GBOX-15A/15B" are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only).
The "VELASII-30A/30B" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (UJrology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis.
The "VELASII-60A/60B/60C" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. Such as: Dermatology, Aesthetics, Plastic Surgery, Vascular Surgery, Podiatry, Endovenous Occlusion of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151890: Medical Diode Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151890
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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