510(k) · Cleared
ClearedFotona XPulse Pro Laser Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fotona D.O.O. · GEX Powered Laser Surgical Instrument
Cleared on Jun 22, 2021 as substantially equivalent to K193656 (Fotona D.O.O., 2020) and 4 other predicates after a 265-day review. Its family tree reaches back 23 generations to 1995. 3 later devices descend from it.
- Decided
- Jun 22, 2021
- Review
- 265 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 23 generations to K943450 (1995). 635 ancestors in all, the oldest K771218 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 2 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 1 generation backK193656 SkyPulseFotona D.O.O. · 2020
- This deviceK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · cites it directly · 1 of its ownK221712 Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm…Fotona D.O.O. · 2022
- Descendant · 2 generations on · 0 of its ownK232885 Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2024
- Descendant · cites it directly · 0 of its ownK220531 Fox 810, Fox 980A.R.C Laser GmbH · 2022
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 11 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 10 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 9 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 6 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 5 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 4 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 3 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 2 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 1 generation backK193656 SkyPulseFotona D.O.O. · 2020
- This deviceK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
Most influential descendants
Showing 3 of 3 · See all- K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O. · 2022 · cites it directly1descendant
- K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2024 · 2 generations on0descendants
- K220531Fox 810, Fox 980A.R.C Laser GmbH · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −11 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −10 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −9 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −6 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −5 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −4 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −3 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −2 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018 | — |
| −1 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| 0 (this device) | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +1 | K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | Fotona D.O.O. | 2022 | — |
| +2 | K232885 | Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024 | — |
| +1 | K220531 | Fox 810, Fox 980 | A.R.C Laser GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 9 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 32 | 0 |
| 1998 | 38 | 0 |
| 1999 | 29 | 0 |
| 2000 | 39 | 0 |
| 2001 | 40 | 0 |
| 2002 | 48 | 0 |
| 2003 | 52 | 0 |
| 2004 | 39 | 0 |
| 2005 | 35 | 0 |
| 2006 | 23 | 0 |
| 2007 | 22 | 0 |
| 2008 | 28 | 0 |
| 2009 | 18 | 0 |
| 2010 | 11 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K193656 | SkyPulseSummary page 5…ent, General and Plastic Surgery 21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICES • Fotona SkyPulse Laser Platform (K193656) • FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322) • Wolf445nm (K192272) • SIROLaser Blue (K180044) • XD Diode… | 2020 |
| * | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810Summary page 5…21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICES • Fotona SkyPulse Laser Platform (K193656) • FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322) • Wolf445nm (K192272) • SIROLaser Blue (K180044) • XD Diode Laser System (K083034)… | 2008 |
| * | K192272 | Wolf445nmSummary page 5…II Product Code: GEX PREDICATE DEVICES • Fotona SkyPulse Laser Platform (K193656) • FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322) • Wolf445nm (K192272) • SIROLaser Blue (K180044) • XD Diode Laser System (K083034)… | 2020 |
| * | K180044 | SIROLaser BlueSummary page 5…PREDICATE DEVICES • Fotona SkyPulse Laser Platform (K193656) • FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322) • Wolf445nm (K192272) • SIROLaser Blue (K180044) • XD Diode Laser System (K083034) 1 of 7 DEVICE DES… | 2018 |
| * | K083034 | Fotona XD-2 Diode Laser System, Model MD01-2FSummary page 5…e Laser Platform (K193656) • FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322) • Wolf445nm (K192272) • SIROLaser Blue (K180044) • XD Diode Laser System (K083034) 1 of 7 DEVICE DESCRIPTION The Fotona XPulse Pro Laser Pla… | 2009 |
What descends from it? (3)
2 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 26 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 30 of the 635 ancestors have a recall of any class.
- Of its descendants, K221712 (Fotona D.O.O., 2022) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K193656.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
810 nm Diode Laser System: * Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: o Gingival troughing for crown impression ° Gingivectomy ° Gingivoplasty ° Gingival incision and excision > Hemostasis and coagulation o Excisional and incisional biopsies o Fibroma removal o Frenectomy and frenotomy o Oral papillectomies ° Soft tissue crown lengthening o Treatment of aphthous ulcers o Treatment of…
Read the full statement (340 words)
810 nm Diode Laser System:
* Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
o Gingival troughing for crown impression
° Gingivectomy
° Gingivoplasty
° Gingival incision and excision
> Hemostasis and coagulation
o Excisional and incisional biopsies
o Fibroma removal
o Frenectomy and frenotomy
o Oral papillectomies
° Soft tissue crown lengthening
o Treatment of aphthous ulcers
o Treatment of herpetic lesions
* Periodontology:
o Laser soft tissue curettage,
o Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket
* Cosmetic Dentistry:
o Laser-assisted bleaching/whitening of the teeth,
o Light activation for bleaching materials for teeth whitening
* Implant recovery
* 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
810 nm Diode Laser Module:
* Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
o Gingival troughing for crown impression
°> Gingivoplasty
o Soft tissue crown lengthening
o Treatment of aphthous ulcers
o Treatment of herpetic lesions
810 nm Diode Laser System & Module in therapy:
* Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
980 nm Diode Laser:
* Gingival troughing
* Crown lengthening
* Gingivoplasty
* Coagulation
* Hemostasis of donor site
* Implant recovery
* Implant uncovery
* Soft tissue curettage
* Sulcular debridement
* Biopsy
* Frenectomy
* Operculectomy
* Exposure of unerupted teeth
* Pulpotomy
* Treatment of aphthous ulcers
* Excision of lesions
* Light activation of bleaching materials for teeth whitening
* 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.
445 nm Diode Laser:
* Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue
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/K202991 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202991: Fotona XPulse Pro Laser Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202991
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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