510(k) · Cleared
ClearedFotona QX ND:Yag/KTP Laser System
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 Feb 16, 2006 as substantially equivalent to K000317 (Tissue Medical Lasers, Inc., 2000) and 2 other predicates after a 99-day review. Its family tree reaches back 2 generations to 1998. 168 later devices descend from it.
- Decided
- Feb 16, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K971207 (1998). 4 ancestors in all. 168 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971207 Softlight Q-Switched (ND:Yag) LaserThermolase Corp. · 1998
- 1 generation backK023967 Palomar Q-Yag ND:Yag Laser SystemPalomar Medical Technologies, Inc. · 2003
- This deviceK053139 Fotona QX ND:Yag/KTP Laser SystemFotona D.D. · 2006
- Descendant · cites it directly · 166 of its ownK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- Descendant · 2 generations on · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
- Descendant · 3 generations on · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
- Descendant · 2 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · 4 generations on · 57 of its ownK133254 Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014
Showing 5 of 168 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 168 · See all- K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009 · cites it directly166descendants
- K103455Spectra Laser SystemLutronic Corporation · 2011 · 2 generations on92descendants
- K113588Spectra Laser SystemLutronic Corporation · 2012 · 3 generations on82descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 2 generations on62descendants
- K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 2014 · 4 generations on57descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971207 | Softlight Q-Switched (ND:Yag) Laser | Thermolase Corp. | 1998 | — |
| −1 | K023967 | Palomar Q-Yag ND:Yag Laser System | Palomar Medical Technologies, Inc. | 2003 | — |
| 0 (this device) | K053139 | Fotona QX ND:Yag/KTP Laser System | Fotona D.D. | 2006 | — |
| +1 | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| +2 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| +3 | K113588 | Spectra Laser System | Lutronic Corporation | 2012 | — |
| +2 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +4 | K133254 | Revlite Q-Switched ND:Yag Laser System | Cynosure, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K000317 | Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRMSummary page 2…Summary of Substantial Equivalence Fotona believes that its Fotona QX laser system is substantially equivalent to the a) Spectra -VRM Q-switched Nd:YAG Laser System (K000317) previously cleared for: Incision, excision, ablation, vaporization of soft tissue for general dermatology - 532 nm wavelen… | 2000 |
| * | K014234 | Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag LaserSummary page 2…oos, treatment of Nevus of Ota, removal or lightening of unwanted hair, treatment of Common Nevi. b) Medlite C6 Q-Switched Nd:YAG Laser (K 014234) previously cleared for incision, excision, ablation, vaporization of soft tissue for general dermatology, Tatoo removal, treat… | 2002 |
| * | K023967 | Palomar Q-Yag ND:Yag Laser SystemSummary page 2…zation of soft tissue for general dermatology, Tatoo removal, treatment of Vascular Lesions and treatment of Pigmented Lesions. c) Palomar Q-YAG Nd:YAG Laser System (K023967) previously cleared for skin resurfacing with or without adjuvant preparation at the 1064 nm wavelength. 510(k) Sub… | 2003 |
What descends from it? (168)
See all 1682 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 8 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083889 (Fotona D.D., 2009) has gone furthest, with 166 descendants of its own.
- 2 other devices also cite its predicate K000317.
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?
1. Incision, excision, ablation, vaporization of soft tissue for general dermatology.
2. 532 nm wavelength:
- removal of light ink (red, tan, purple, and orange) tatoosf-
- removal of pigmented lesions, removal of vascular lesions,
- treatment of Lentigines, treatment of Cafe-Au-Lait,
- treatment of Common Nevi,
- treatment of Seborrheic Kearotoses,
- treatment of Post Inflammatory Hyperpigmentation.
3. 1064 nm wavelength:
- removal of dark ink (black, blue and brown) tattoos,
- treatment of Nevus of Ota,
- removal or lightening of unwanted hair,
- treatment of Common Nevi.
- skin resurfacing with or without adjuvant preparation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053139: Fotona QX ND:Yag/KTP Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053139
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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