510(k) · Cleared
ClearedDiode Laser System model Dawn-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · GEX Powered Laser Surgical Instrument
Cleared on Dec 26, 2024 as substantially equivalent to K212734 (Triangel Rsd Limited, 2023) and 2 other predicates after a 90-day review. Its family tree reaches back 22 generations to 1995.
- Decided
- Dec 26, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K943450 (1995). 372 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK112253 Ceralas 147NM Diode Laser SystemBiolitec, Inc. · 2011
- 2 generations backK152722 neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd. · 2015
- 1 generation backK240644 Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd. · 2024
- This deviceK243037 Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2024
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 17 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 16 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 15 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 14 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 10 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 9 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 8 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 5 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 4 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 3 generations backK112253 Ceralas 147NM Diode Laser SystemBiolitec, Inc. · 2011
- 2 generations backK152722 neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd. · 2015
- 1 generation backK240644 Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd. · 2024
- This deviceK243037 Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −17 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −16 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −15 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −14 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −10 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −9 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −8 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −5 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| −4 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| −3 | K112253 | Ceralas 147NM Diode Laser System | Biolitec, Inc. | 2011 | — |
| −2 | K152722 | neoV980 & neoV1470 Diode Lasers | G.N.S Neolaser, Ltd. | 2015 | — |
| −1 | K240644 | Medical Diode Laser (S1Pro) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
| 0 (this device) | K243037 | Diode Laser System model Dawn-S | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024 | — |
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 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 18 | 0 |
| 1995 | 18 | 0 |
| 1996 | 24 | 0 |
| 1997 | 29 | 0 |
| 1998 | 26 | 0 |
| 1999 | 19 | 0 |
| 2000 | 29 | 0 |
| 2001 | 30 | 0 |
| 2002 | 36 | 0 |
| 2003 | 30 | 0 |
| 2004 | 20 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K212734 | Diode laser therapy deviceSummary page 6…10(k) Summary 1 - 510 (k) number: K212734 Trade name: Diode Laser Therapy Device Product code: GEX… | 2023 |
| * | K240747 | Medical Diode Laser (M2-GK)Summary page 6…34 Trade name: Diode Laser Therapy Device Product code: GEX 510(K) number:K240747 Predicate Device name: Medical Diode Laser Devices:… | 2024 |
| * | K240644 | Medical Diode Laser (S1Pro)Summary page 6…Device name: Medical Diode Laser Devices: Product code: GEX 510 (k) number: K240644 Device name: Medical Diode Laser Product code: GEX 5. Descriptio… | 2024 |
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 29 years and passes through 9 companies; a new generation was cleared every 9 months on median.
- 16 of the 372 ancestors have a recall of any class.
- 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. 2024, 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 Diode Laser System model Dawn-S is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues in surgical application. The 980nm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngoloty), dental…
Read the full statement (165 words)
The Diode Laser System model Dawn-S is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues in surgical application.
The 980nm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngoloty), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, and gynecology. The laser is further indicated for laser assisted lipolysis.
The 1470nm diode laser is 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, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular, coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The laser is further indicated for laser assisted lipolysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243037: Diode Laser System model Dawn-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243037
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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