510(k) · Cleared
ClearedFotona XP ND: Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fotona D.D. · PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Cleared on Mar 28, 2012 as substantially equivalent to K103626 (Cutera, Inc., 2011) and 1 other predicate after a 103-day review. Its family tree reaches back 9 generations to 1994. 65 later devices descend from it.
- Decided
- Mar 28, 2012
- Review
- 103 days
- Class
- Class II
- Product code
- PDZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K936109 (1994). 112 ancestors in all, the oldest K820106 (1982). 65 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations between
- 3 generations backK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- 2 generations backK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010
- 1 generation backK103626 Cutera Genesisplus Laser SystemCutera, Inc. · 2011
- This deviceK113702 Fotona XP ND: Yag Laser SystemFotona D.D. · 2012
- Descendant · cites it directly · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · 2 generations on · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- Descendant · 3 generations on · 24 of its ownK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- Descendant · 4 generations on · 22 of its ownK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- Descendant · 2 generations on · 20 of its ownK182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018
Show all 9 generations
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 7 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 6 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 5 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 4 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 3 generations backK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- 2 generations backK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010
- 1 generation backK103626 Cutera Genesisplus Laser SystemCutera, Inc. · 2011
- This deviceK113702 Fotona XP ND: Yag Laser SystemFotona D.D. · 2012
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · cites it directly62descendants
- K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016 · 2 generations on32descendants
- K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc. · 2017 · 3 generations on24descendants
- K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc. · 2018 · 4 generations on22descendants
- K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 2018 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −8 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −6 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −5 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −4 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −3 | K083215 | Incisive Family of Inpulse ND:Yag Lasers | Incisive, LLC | 2009 | — |
| −2 | K093545 | Pinpointe Footlaser Model 6W, 30W, 100W | Incisive, Inc. (Formerly Named Incisive, LLC) | 2010 | — |
| −1 | K103626 | Cutera Genesisplus Laser System | Cutera, Inc. | 2011 | — |
| 0 (this device) | K113702 | Fotona XP ND: Yag Laser System | Fotona D.D. | 2012 | — |
| +1 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +2 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| +3 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| +4 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| +2 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 10 | 0 |
| 1997 | 11 | 0 |
| 1998 | 10 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 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 PDZ? 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 PDZ device
- #1 K253960 Medicell Mycosis Laser (MCML24004)score 11.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K103626 | Cutera Genesisplus Laser SystemSummary page 2…Candida albicans, etc.) 510(k) Submission: Fotona XP Nd:YAG Laser System Family / vl 13/37 PREDICATE DEVICES - k11792 Vflfi?@) "{@ - Cutera GenesisPlus (K103626) - PinPointe FootLaser (K093547) ' SUMMARY OF TECHNOLOGICAL CHARACTERISTICS The Fotona XP Laser System Family has identical tec… | 2011 |
| * | K093547 | Pinpointe FootlaserSummary page 2…Submission: Fotona XP Nd:YAG Laser System Family / vl 13/37 PREDICATE DEVICES - k11792 Vflfi?@) "{@ - Cutera GenesisPlus (K103626) - PinPointe FootLaser (K093547) ' SUMMARY OF TECHNOLOGICAL CHARACTERISTICS The Fotona XP Laser System Family has identical technological and similar design ch… | 2010 |
What descends from it? (65)
See all 652 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 18 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 112 ancestors have a recall of any class.
- Of its descendants, K143723 (Fotona D.D., 2015) has gone furthest, with 62 descendants of its own.
- 6 other devices also cite its predicate K103626.
How does its category compare?
All PDZ devicesPDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · PDZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PDZ
196in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDZ
No recall names PDZ since 2007.
Adverse event reports per year · PDZ
1in 2019
MAUDE reports naming product code PDZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 205 | 0 | 0 |
| 2012 | 6 | 196 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Fotona XP Nd:YAG Laser System Family is indicated for podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Radical nail excision
- Periungual and subungual warts
- Plantar warts
- Neuromas
- Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Teichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
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/K113702 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113702: Fotona XP ND: Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113702
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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