510(k) · Cleared
ClearedFox 1-980, Fox Q-1064, Fox-Q-810
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.R.C Laser GmbH · GEX Powered Laser Surgical Instrument
Cleared on Feb 22, 2008 as substantially equivalent to K062619 (CAO Group, Inc., 2006) and 2 other predicates after an 88-day review. Its family tree reaches back 16 generations to 1995. 22 later devices descend from it.
- Decided
- Feb 22, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K943450 (1995). 175 ancestors in all, the oldest K800617 (1980). 22 later devices descend from it, 6 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- This deviceK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- Descendant · cites it directly · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 8 of its ownK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- Descendant · cites it directly · 7 of its ownK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- Descendant · 2 generations on · 6 of its ownK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- Descendant · cites it directly · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- This deviceK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K193656SkyPulseFotona D.O.O. · 2020 · cites it directly11descendants
- K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009 · cites it directly8descendants
- K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010 · cites it directly7descendants
- K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013 · 2 generations on6descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −3 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −2 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −1 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| 0 (this device) | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810 | A.R.C Laser GmbH | 2008 | — |
| +1 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | K091562 | Doctor Smile a-810 and B-980 Lasers | Lambda Scientific Spa | 2009 | — |
| +1 | K102036 | Doctor Surgery Diode Lasers Family | Lambda S.P.A. | 2010 | — |
| +2 | K122567 | Joule 810/940/980 Multi-Platform System | Sciton, Inc | 2013 | — |
| +1 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 13 | 0 |
| 1996 | 14 | 0 |
| 1997 | 18 | 0 |
| 1998 | 9 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 14 | 0 |
| 2002 | 17 | 0 |
| 2003 | 13 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 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 |
|---|---|---|---|
| * | K062619 | Denlaser 800 PlusSummary page 1…Fox Q-810, Q-980 and Q-1 064 Lasers Device Common Name: Diode Laser Classification Name: Laser Surgical Instrument Predicate Devices: Fox Q-810 (K062619), Ceralas 980 (K072106) and Laserscope 1064 (K990903) Device Description: Fox Q-810, Q-980 and Q-… | 2006 |
| * | K072106 | 150W Ceralas D 980NM Diode LaserSummary page 1…d Q-1 064 Lasers Device Common Name: Diode Laser Classification Name: Laser Surgical Instrument Predicate Devices: Fox Q-810 (K062619), Ceralas 980 (K072106) and Laserscope 1064 (K990903) Device Description: Fox Q-810, Q-980 and Q-1064 are standard diode… | 2007 |
| * | K990903 | Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)Summary page 1…Classification Name: Laser Surgical Instrument Predicate Devices: Fox Q-810 (K062619), Ceralas 980 (K072106) and Laserscope 1064 (K990903) Device Description: Fox Q-810, Q-980 and Q-1064 are standard diode medical lasers with 810, 980nm… | 1999 |
What descends from it? (22)
See all 226 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 13 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 8 of the 175 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.
- 4 other devices also cite its predicate K062619.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Fox Q-810: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology. Fox Q-980: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in…
Read the full statement (105 words)
Fox Q-810:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology.
Fox Q-980:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Fox Q-1 064:
indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073322: Fox 1-980, Fox Q-1064, Fox-Q-810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073322
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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