510(k) · Cleared
ClearedFotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fotona D.D. · GEX Powered Laser Surgical Instrument
Cleared on Jun 29, 2009 as substantially equivalent to K070355 (Fotona D.D., 2008) and 10 other predicates after a 159-day review. Its family tree reaches back 10 generations to 1995. 80 later devices descend from it.
- Decided
- Jun 29, 2009
- Review
- 159 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 10 generations to K943450 (1995). 146 ancestors in all, the oldest K800617 (1980). 80 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 2 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 1 generation backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- This deviceK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- Descendant · cites it directly · 78 of its ownK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- Descendant · 2 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · cites it directly · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · cites it directly · 33 of its ownK120235 Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag…Aerolase Medical Lasers, LLC · 2012
- Descendant · 2 generations on · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 4 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 3 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 2 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 1 generation backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- This deviceK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D. · 2011 · cites it directly78descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 2 generations on70descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · cites it directly62descendants
- K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC · 2012 · cites it directly33descendants
- K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016 · 2 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −4 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −3 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −2 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| −1 | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | Diomed, Ltd. | 2005 | — |
| 0 (this device) | K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP… | Fotona D.D. | 2009 | — |
| +1 | K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models… | Fotona D.D. | 2011 | — |
| +2 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +1 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +1 | K120235 | Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers… | Aerolase Medical Lasers, LLC | 2012 | — |
| +2 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 15 | 0 |
| 1997 | 17 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 13 | 0 |
| 2001 | 12 | 0 |
| 2002 | 18 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 11 | 0 |
| 2023 | 7 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 9 | 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? (11)
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 |
|---|---|---|---|
| * | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilySummary page 3…ms of its indications for use, technical specifications, operating performance features, and general design features: a) Fotona Fidelis III Er:YAG/ Nd:YAG Laser System (K070355), previously cleared for: Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas: - Removal of unwanted hair,… | 2008 |
| * | K030290 | Periolase ND:Yag Dental Laser SystemSummary page 3…tachment loss, and tooth mobility) - Tissue retraction for impression - Treatment of aphtous ulcers - Vestibuloplasty b) Millennium Periolase Nd:YAG Laser System (K030290) previously cleared for: - Ablation, incision, excision, vaporization and coagulation of soft tissues using a contact fiber o… | 2004 |
| * | K061618 | Cooltouch, Model CtevSummary page 4…livery system 510(k) Submission Fotona XP Nd:YAG Laser System Family / v2 17/70 c) Cooltouch Nd:YAG Laser System (K061618), Dornier Medilas D family (K073427) and Diomed Delta family of laser systems (K051996) previously cleared for: Endo Venou… | 2006 |
| * | K073427 | Medilas D Family LasersSummary page 4…ion Fotona XP Nd:YAG Laser System Family / v2 17/70 c) Cooltouch Nd:YAG Laser System (K061618), Dornier Medilas D family (K073427) and Diomed Delta family of laser systems (K051996) previously cleared for: Endo Venous Laser Therapy of superficial incom… | 2008 |
| * | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Summary page 4…17/70 c) Cooltouch Nd:YAG Laser System (K061618), Dornier Medilas D family (K073427) and Diomed Delta family of laser systems (K051996) previously cleared for: Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose ve… | 2005 |
| * | K062321 | Smartlipo ND:Yag LaserSummary page 4…aser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities d) Cynosure SmartLipo and SmartLipo MPX Nd:YAG laser system (K062321, K080121), and Syneron LipoLite (eLipo) (K073715) previously cleared for: - Surgical incison, excision, vaporization, abla… | 2006 |
| * | K080121 | Cynosure Smartlipo Multiwavlength LaserSummary page 4…apy of superficial incompetent tributary veins associated with varicose veins and varicosities d) Cynosure SmartLipo and SmartLipo MPX Nd:YAG laser system (K062321, K080121), and Syneron LipoLite (eLipo) (K073715) previously cleared for: - Surgical incison, excision, vaporization, ablation and… | 2008 |
| * | K073715 | ELIPOSummary page 4…ns associated with varicose veins and varicosities d) Cynosure SmartLipo and SmartLipo MPX Nd:YAG laser system (K062321, K080121), and Syneron LipoLite (eLipo) (K073715) previously cleared for: - Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue… | 2008 |
| * | K033172 | Candela Gentleyag Family of Laser SystemsSummary page 4…cus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis e) Candela GentleYAG Family of Laser Systems (K033172) previously cleared for: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PF… | 2003 |
| * | K040131 | Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemSummary page 4…ngiectasiae, rosacea, venus lake, leg veins and spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles f) Cooltouch Nd:YAG Laser System (K040131) and Laserscope Gemini Laser System (K034011) previously cleared for: - Treatment of mild to moderate inflammatory acne vulgar… | 2004 |
| * | K034011 | Gemini Surgical Laser System & AccessoriesSummary page 4…nd spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles f) Cooltouch Nd:YAG Laser System (K040131) and Laserscope Gemini Laser System (K034011) previously cleared for: - Treatment of mild to moderate inflammatory acne vulgaris Details are provided in the Substantia… | 2004 |
What descends from it? (80)
See all 806 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models… | 2011 | 78 |
| K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | 2015 | 62 |
| K120235 | Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo… | 2012 | 33 |
| K132286 | Hyperion Long Pulsed ND: Yag Laser | 2014 | 3 |
| K202288 | Finebeam | 2021 | 2 |
| K121508 | Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N | 2012 | 1 |
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 14 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 146 ancestors have a recall of any class.
- Of its descendants, K101306 (Fotona D.D., 2011) has gone furthest, with 78 descendants of its own.
- 3 other devices also cite its predicate K070355.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas: - Surgical incison, excision, vaporization,, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of…
Read the full statement (306 words)
Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas:
- Surgical incison, excision, vaporization,, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
- Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities
Nd:YAG laser (10'64 nm wavelength) in dentistry:
- Excisional and incisional biopsies
- Excision and vaporization of herpes simplex I and II
- Exposure of unerupted teeth
- Fibroma removal
- Frenectomy and frenotomy
- Gingival troughing for crown impressions
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis
- Implant recovery
- Incision and drainage of abscess
- Laser assisted uvulopaletoplasty (LAUP)
- Operculectomy
- Oral papillectomies
- Pulpotomy and pulpotomy as an adjunct to root canal therapy
- Reduction of denture hyperplasia
- Reduction of gingival hypertrophy
- Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
- Removal of post-surgical granulations
- Soft tissue crown lengthening
- Sulcular debridement or soft tissue curettage (removal of diseased or imfiamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility)
- Tissue retraction for impression
- Treatment of aphtous ulcers
- Vestibuloplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090126
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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