510(k) · Cleared
ClearedneoV980 & neoV1470 Diode Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G.N.S Neolaser, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Dec 8, 2015 as substantially equivalent to K100558 (Quanta System Spa, 2010) and 2 other predicates after a 77-day review. Its family tree reaches back 20 generations to 1995. 17 later devices descend from it.
- Decided
- Dec 8, 2015
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K943450 (1995). 358 ancestors in all, the oldest K771218 (1978). 17 later devices descend from it, 5 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 2 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 1 generation backK112253 Ceralas 147NM Diode Laser SystemBiolitec, Inc. · 2011
- This deviceK152722 neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd. · 2015
- Descendant · cites it directly · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 4 of its ownK240747 Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · cites it directly · 2 of its ownK240644 Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
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 backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 3 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 2 generations backK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- 1 generation backK112253 Ceralas 147NM Diode Laser SystemBiolitec, Inc. · 2011
- This deviceK152722 neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd. · 2015
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K193656SkyPulseFotona D.O.O. · 2020 · cites it directly11descendants
- K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd. · 2024 · cites it directly4descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 2 generations on3descendants
- K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd. · 2024 · cites it directly2descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 2 generations on2descendants
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 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −3 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| −2 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| −1 | K112253 | Ceralas 147NM Diode Laser System | Biolitec, Inc. | 2011 | — |
| 0 (this device) | K152722 | neoV980 & neoV1470 Diode Lasers | G.N.S Neolaser, Ltd. | 2015 | — |
| +1 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | K240747 | Medical Diode Laser (M2-GK) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
| +2 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +1 | K240644 | Medical Diode Laser (S1Pro) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
| +2 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology 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 | 23 | 0 |
| 1997 | 28 | 0 |
| 1998 | 25 | 0 |
| 1999 | 17 | 0 |
| 2000 | 28 | 0 |
| 2001 | 30 | 0 |
| 2002 | 36 | 0 |
| 2003 | 30 | 0 |
| 2004 | 19 | 0 |
| 2005 | 12 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K100558 | Quanta Diode Laser SystemSummary page 4…Instrument, surgical, powered laser GEX 21 CFR 878.4810 Predicate Devices: Quanta Diode Laser Family (K100558), Ceralas 1470nm Diode Laser (K112253) and Ceralas 980nm Diode Laser (K112324) Device Descr… | 2010 |
| * | K112253 | Ceralas 147NM Diode Laser SystemSummary page 4…EX 21 CFR 878.4810 Predicate Devices: Quanta Diode Laser Family (K100558), Ceralas 1470nm Diode Laser (K112253) and Ceralas 980nm Diode Laser (K112324) Device Description: neoV980 & neoV1470, members of the neoV Diode Lasers… | 2011 |
| * | K112324 | Ceralas 980NM Diode Laser FamilySummary page 4…Predicate Devices: Quanta Diode Laser Family (K100558), Ceralas 1470nm Diode Laser (K112253) and Ceralas 980nm Diode Laser (K112324) Device Description: neoV980 & neoV1470, members of the neoV Diode Lasers family, cleared unde… | 2011 |
What descends from it? (17)
See all 175 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 7 companies; a new generation was cleared every 9 months on median.
- 16 of the 358 ancestors have a recall of any class.
- Of its descendants, K193656 (Fotona D.O.O., 2020) has gone furthest, with 11 descendants of its own.
- 13 other devices also cite its predicate K100558.
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 neoV980 & neoV1470 Diode Lasers, (and their delivery accessories used to deliver optical energy) 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 specialties including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry…
Read the full statement (89 words)
The neoV980 & neoV1470 Diode Lasers, (and their delivery accessories used to deliver optical energy) 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 specialties 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 greatest saphenous vein in patients with superficial vein reflux.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152722: neoV980 & neoV1470 Diode Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152722
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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