510(k) · Cleared
ClearedFotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of Laser Systems
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 Mar 18, 2005 as substantially equivalent to K033172 (Candela Corp., 2003) and 3 other predicates after a 39-day review. Its family tree reaches back 8 generations to 1992. 200 later devices descend from it.
- Decided
- Mar 18, 2005
- Review
- 39 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K910422 (1992). 96 ancestors in all, the oldest K820106 (1982). 200 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 2 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 1 generation backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- This deviceK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- Descendant · cites it directly · 194 of its ownK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- Descendant · 2 generations on · 166 of its ownK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- Descendant · 3 generations on · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
- Descendant · cites it directly · 83 of its ownK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
- Descendant · 4 generations on · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
Showing 5 of 200 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 200 · See all- K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008 · cites it directly194descendants
- K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009 · 2 generations on166descendants
- K103455Spectra Laser SystemLutronic Corporation · 2011 · 3 generations on92descendants
- K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D. · 2010 · cites it directly83descendants
- K113588Spectra Laser SystemLutronic Corporation · 2012 · 4 generations on82descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −3 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −2 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −1 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| +3 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| +1 | K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at… | Fotona D.D. | 2010 | — |
| +4 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
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 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 13 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 10 | 0 |
| 2021 | 14 | 0 |
| 2022 | 24 | 0 |
| 2023 | 13 | 0 |
| 2024 | 21 | 0 |
| 2025 | 26 | 0 |
| 2026 | 19 | 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? (4)
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 |
|---|---|---|---|
| * | K033172 | Candela Gentleyag Family of Laser Systems | 2003 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 5…nism of action, technological features as the predicate devices Candela GentleYAG Family of Laser Systems (KO33 172), Family of Altus Medical CoolGlide Aesthetic Lasers (K023954, K022226) and Fotona Dualis XP Plus (K002839) and therefore is substantially equivalent to the predicate devices.… | 2003 |
| * | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Summary page 5…ction, technological features as the predicate devices Candela GentleYAG Family of Laser Systems (KO33 172), Family of Altus Medical CoolGlide Aesthetic Lasers (K023954, K022226) and Fotona Dualis XP Plus (K002839) and therefore is substantially equivalent to the predicate devices.… | 2002 |
| * | K022839 | Fotona Dualis Plus ND:Yag Laser System Our reading of the summary gave K002839, FDA’s number for End Expiratory Filter, Model RT020 (Fisher & Paykel Healthcare, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Fotona Dualis XP Plus”. | 2002 |
What descends from it? (200)
See all 2004 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | 2008 | 194 |
| K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis… | 2010 | 83 |
| 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 |
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 1.4 years on median.
- 2 of the 96 ancestors have a recall of any class.
- Of its descendants, K070355 (Fotona D.D., 2008) has gone furthest, with 194 descendants of its own.
- 9 other devices also cite its predicate K033172.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of I'FB. The lasers are indicated on 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, hernoangioma, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Incision/excision of soft body…
Read the full statement (196 words)
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of I'FB. The lasers are indicated on 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, hernoangioma, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Incision/excision of soft body tissue in dermatology
Soft tissue general surgery applications-skin incision; tissue dissection; cornpelte or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafd au lait macules, seborrheic keratosis, nevi, chloasma, vermcae, skin tags, keratosis, tattoos (significant reduction in the intensity of black andlor blue-black tatoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation and hypertrophic and keloid scars where vascularity is an integral part of the scar.
'rrcatment of wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050293 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050293: Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050293
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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