510(k) · Cleared
ClearedFotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
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 Oct 12, 2022 as substantially equivalent to K193656 (Fotona D.O.O., 2020) and 2 other predicates after a 121-day review. Its family tree reaches back 24 generations to 1995. 1 later device descends from it.
- Decided
- Oct 12, 2022
- Review
- 121 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 24 generations to K943450 (1995). 638 ancestors in all, the oldest K771218 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations between
- 3 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 2 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 1 generation backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- This deviceK221712 Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm…Fotona D.O.O. · 2022
- Descendant · cites it directly · 0 of its ownK232885 Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2024
Show all 24 generations
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 20 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 19 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 18 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 17 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 16 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 13 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 12 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 11 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 10 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 9 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 7 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 6 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 5 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 4 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 3 generations backK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
- 2 generations backK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- 1 generation backK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- This deviceK221712 Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm…Fotona D.O.O. · 2022
Most influential descendants
Showing 1 of 1 · See all- K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −23 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −20 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −19 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −18 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −17 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −16 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −13 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −12 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −11 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −10 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −9 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −7 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −6 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −5 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −4 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −3 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018 | — |
| −2 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
| −1 | K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 | — |
| 0 (this device) | K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | Fotona D.O.O. | 2022 | — |
| +1 | K232885 | Dawn Diode Laser System | 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 | 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 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K193656 | SkyPulseSummary page 6…ent, General and Plastic Surgery 21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICES • Fotona SkyPulse Laser Platform (K193656) • Fotona XPulse Pro Laser Platform (K202991) • Fotona LightWalker Laser System Family (K202985)… | 2020 |
| * | K202991 | Fotona XPulse Pro Laser PlatformSummary page 6…21 CFR 878.4810, Class II Product Code: GEX PREDICATE DEVICES • Fotona SkyPulse Laser Platform (K193656) • Fotona XPulse Pro Laser Platform (K202991) • Fotona LightWalker Laser System Family (K202985) K22171… | 2021 |
| * | K202985 | LightWalker Laser System FamilySummary page 6…PREDICATE DEVICES • Fotona SkyPulse Laser Platform (K193656) • Fotona XPulse Pro Laser Platform (K202991) • Fotona LightWalker Laser System Family (K202985) K221712 Page 2 of… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232885 | Dawn Diode Laser System | 2024 | 0 |
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 27 years and passes through 9 companies; a new generation was cleared every 12 months on median.
- 30 of the 638 ancestors have a recall of any class.
- Of its descendants, K232885 (Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd, 2024) has gone furthest, with 0 descendants 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. 2022, 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?
1064 nm Diode Laser in dentistry: * Excisional and incisional biopsies » Excision and vaporization of herpes simplex I and II * Frenectomy and frenotomy * Gingivectomy * Gingivoplasty * Gingival incision and excision » Hemostasis * Implant recovery * Operculectomy * Pulpotomy and pulpotomy as an adjunct to root canal therapy » Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy » Sulcular debridement…
Read the full statement (518 words)
1064 nm Diode Laser in dentistry:
* Excisional and incisional biopsies
» Excision and vaporization of herpes simplex I and II
* Frenectomy and frenotomy
* Gingivectomy
* Gingivoplasty
* Gingival incision and excision
» Hemostasis
* Implant recovery
* Operculectomy
* Pulpotomy and pulpotomy as an adjunct to root canal therapy
» Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
» Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility)
* Treatment of aphthous ulcers and herpetic lesions
1064 nm Diode Laser in dermatology and other surgical areas:
* General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal.
* Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
» Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.)
1064 nm Diode Laser in therapy:
» Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
810 nm Diode Laser in dentistry:
» 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
* Oral/Maxillofacial Indications: Incision, excision, vaporization, ablation and/or coagulation of soft tissue
o Gingival troughing for crown impression
° Gingivectomy
° Gingivoplasty
° Gingival incision and excision
> Hemostasis and coagulation
° Excisional and incisional biopsies
o Fibroma removal
° Frenectomy and frenotomy
° Oral papillectomies
> Soft tissue crown lengthening
o Treatment of aphthous ulcers
> 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
810 nm Diode Laser 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 in dentistry:
» 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
* Gingival troughing
* Crown lengthening
* Gingivoplasty
* Coagulation
* Implant uncovery
* Implant recovery
* Soft tissue curettage
* Sulcular debridement
* Biopsy
* Frenectomy
» Hemostasis of donor site
* Operculectomy
* Exposure of unerupted teeth
* Pulpotomy
* Treatment of aphthous ulcers
* Excision of lesions
» Light activation of bleaching materials for teeth whitening
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/K221712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221712: Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221712
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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