510(k) · Cleared
ClearedNeov Diode Laser Family
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 Apr 17, 2014 as substantially equivalent to K100558 (Quanta System Spa, 2010) and 1 other predicate after a 204-day review. Its family tree reaches back 18 generations to 1995. 13 later devices descend from it.
- Decided
- Apr 17, 2014
- Review
- 204 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K943450 (1995). 379 ancestors in all, the oldest K771218 (1978). 13 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 1 generation backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- This deviceK133006 Neov Diode Laser FamilyG.N.S Neolaser, Ltd. · 2014
- Descendant · cites it directly · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 2 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · 2 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK230274 Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK241791 Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D…Gigaalaser Company, Ltd. · 2025
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 4 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 1 generation backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- This deviceK133006 Neov Diode Laser FamilyG.N.S Neolaser, Ltd. · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K193656SkyPulseFotona D.O.O. · 2020 · cites it directly11descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 2 generations on3descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 2 generations on2descendants
- K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd. · 2023 · 2 generations on2descendants
- K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −5 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −4 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −1 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| 0 (this device) | K133006 | Neov Diode Laser Family | G.N.S Neolaser, Ltd. | 2014 | — |
| +1 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +2 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +2 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
| +2 | K230274 | Medical Diode Laser (M2) | Wuhan Pioon Technology Co., Ltd. | 2023 | — |
| +2 | K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS… | Gigaalaser Company, Ltd. | 2025 | — |
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 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 8 | 0 |
| 1992 | 6 | 0 |
| 1993 | 11 | 0 |
| 1994 | 22 | 0 |
| 1995 | 19 | 0 |
| 1996 | 25 | 0 |
| 1997 | 29 | 0 |
| 1998 | 29 | 0 |
| 1999 | 19 | 0 |
| 2000 | 29 | 0 |
| 2001 | 32 | 0 |
| 2002 | 36 | 0 |
| 2003 | 30 | 0 |
| 2004 | 19 | 0 |
| 2005 | 12 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 | 3 | 0 |
| 2025 | 4 | 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? (2)
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 1…Instrument, surgical, powered laser GEX 21 CFR 878.4810 Predicate Devices: Quanta Diode Laser Family (K100558) Sheaumann Laser PL- 1064 (K 12093 8) Device Description: The neoV Diode Laser Family… | 2010 |
| * | K120938 | The PL-1064 Laser SystemSummary page 1…GEX 21 CFR 878.4810 Predicate Devices: Quanta Diode Laser Family (K100558) Sheaumann Laser PL- 1064 (K 12093 8) Device Description: The neoV Diode Laser Family are medical grade, solid-state, infrared diode… | 2012 |
What descends from it? (13)
See all 132 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 19 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 17 of the 379 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. 2014, 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 neoVi 10 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and liemostasis, or coagulation of soft tissue in conjuriction with endoscopic equipment for medical specialist including: Urology, Thomuic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology. Orthopedics, Podiatry, Arthroscopy, Spinal Surgery. Gynecology, Pulmonary Surgery, Neurosurgery…
Read the full statement (250 words)
The neoVi 10 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and liemostasis, or coagulation of soft tissue in conjuriction with endoscopic equipment for medical specialist including: Urology, Thomuic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology. Orthopedics, Podiatry, Arthroscopy, Spinal Surgery. Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Hesd/neck/EI'T and Radiology, Oral Surgery and Dental procedures.
The neoV9SO diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemnostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, Genera] Surgery, Ophthalmology, Orthopedics, Podiatry, Artroscopy, Spinal Surgery, Gynecology. Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/nect/ENT and Radiology, Oral Surgery and Dental procedures.
The neoVlO064 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 endoscorpic 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/tneck/ENT and Radiology, Oral Surgery and Dental procedures-
The neoVI 470 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 fbr medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology. General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthioscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Hcad/nck/EU and Radiology, Oral Surgery and Dental. procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133006: Neov Diode Laser Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133006
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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