510(k) · Cleared
ClearedFotona QX ND:Yag/KTP Laser System Family
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 Apr 23, 2009 as substantially equivalent to K053139 (Fotona D.D., 2006) and 5 other predicates after a 115-day review. Its family tree reaches back 10 generations to 1992. 166 later devices descend from it.
- Decided
- Apr 23, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K910422 (1992). 124 ancestors in all, the oldest K820106 (1982). 166 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 1 generation backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- This deviceK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- Descendant · cites it directly · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
- Descendant · 2 generations on · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
- Descendant · cites it directly · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · 3 generations on · 57 of its ownK133254 Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014
- Descendant · 4 generations on · 49 of its ownK143105 Picosure WorkstationCynosure, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 1 generation backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- This deviceK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
Showing 5 of 166 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 166 · See all- K103455Spectra Laser SystemLutronic Corporation · 2011 · cites it directly92descendants
- K113588Spectra Laser SystemLutronic Corporation · 2012 · 2 generations on82descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · cites it directly62descendants
- K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014 · 3 generations on57descendants
- K143105Picosure WorkstationCynosure, Inc. · 2015 · 4 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −1 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| 0 (this device) | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| +1 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| +2 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
| +1 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +3 | K133254 | Revlite Q-Switched ND:Yag Laser System | Cynosure, Inc. | 2014 | — |
| +4 | K143105 | Picosure Workstation | Cynosure, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 16 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 10 | 0 |
| 2019 | 6 | 0 |
| 2020 | 10 | 0 |
| 2021 | 12 | 0 |
| 2022 | 20 | 0 |
| 2023 | 13 | 0 |
| 2024 | 20 | 0 |
| 2025 | 26 | 0 |
| 2026 | 18 | 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? (6)
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 |
|---|---|---|---|
| * | K053139 | Fotona QX ND:Yag/KTP Laser SystemSummary page 2…vices in terms of its indications for use, technical specifications, operating performance features, and general design features: a) Fotona QX Nd:YAG/KTP Laser System (K053139) previously cleared for: Incision, excision, ablation, vaporization of soft tissue for general dermatology. Q-switched Nd:YAG 106… | 2006 |
| * | K063834 | Revlite C6 Q-Switched ND:Yag Laser SystemSummary page 2…treatment of common nevi - treatment of seborrheic keratosis - treatment of post inflammatory hyperpigmentation b) Hoya RevLite Q-Switched Nd:YAG Laser System (1{063834) previously cleared for: Incision, excision, ablation, vaporization of soft tissue for general dermatology. Q-switched 1064 nm… | 2007 |
| * | K033172 | Candela Gentleyag Family of Laser SystemsSummary page 2…'s nevi - freckles - nevus spilus - Skin resurfacing procedures for the treatment of acne scars and wrinkles c) Candela GentleYAG Family of Laser Systems (K033172) previously cleared for: Non-Q-Switched 1064 nm Nd:YAG wavelength: - Removal of unwanted hair, for stable long term or permanen… | 2003 |
| * | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilySummary page 3…lake, leg veins and spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles d) Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K070355) previously cleared for: Non-O-Switched 1064 nm Nd:YAG wavelength: - Removal of unwanted hair, for stable long term or permane… | 2008 |
| * | K040131 | Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemSummary page 3…sacea, venus lake, leg veins and spider veins - Treatment of wrinkles - Treatment of mild to moderate inflarmmatory acne vulgaris e) Cooltouch Nd:YAG Laser System (K040131) previously cleared for: - Treatment of mild to moderate inflanmnatory acne vulgaris I) Palomar StarLux Pulsed Light System (K04… | 2004 |
| * | K041086 | Palomar Starlux Pulsed Light SystemSummary page 3…e) Cooltouch Nd:YAG Laser System (K040131) previously cleared for: - Treatment of mild to moderate inflanmnatory acne vulgaris I) Palomar StarLux Pulsed Light System (K041086) previously cleared for: - Treatment of mild to moderate inflammatory acne vulgaris Details are provided in the Substantial Equ… | 2005 |
What descends from it? (166)
See all 1667 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 17 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 124 ancestors have a recall of any class.
- Of its descendants, K103455 (Lutronic Corporation, 2011) has gone furthest, with 92 descendants of its own.
- 1 other device also cites its predicate K053139.
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?
The Fotona QX Nd:YAG/KTP Laser System Family is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology. Specific Indications: 1064 nm wavelength in Q-switched mode: - Removal of dark ink (black, blue and brown) tattoos - Treatment of nevus of Ota - Treatment of common nevi - Removal or lightening of unwanted hair - Skin resurfacing procedures for the treatement of acne scars and wrinkles 1064 nm wavelength in…
Read the full statement (268 words)
The Fotona QX Nd:YAG/KTP Laser System Family is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology.
Specific Indications:
1064 nm wavelength in Q-switched mode:
- Removal of dark ink (black, blue and brown) tattoos
- Treatment of nevus of Ota
- Treatment of common nevi
- Removal or lightening of unwanted hair
- Skin resurfacing procedures for the treatement of acne scars and wrinkles
1064 nm wavelength in non- Q-switched mode:
- 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
- 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
- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532 un wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):
- Removal of light ink (red, sky blue, green, tan, purple, and orange) tatoos
- Treatment of vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angiomaa
- Treatment of pigmented lesions including, but not limited to:
- cafe-au-Iait birthmarks
- solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Treatment of seborrheic keratosis
- Treatment of post inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083889: Fotona QX ND:Yag/KTP Laser System Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083889
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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