510(k) · Cleared
ClearedFotona Dualis Plus ND:Yag 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 Nov 25, 2002 after a 90-day review. The FDA summary names its predicate without a number. 251 later devices descend from it.
- Decided
- Nov 25, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
251 later devices descend from it, 2 citing it directly.
- This deviceK022839 Fotona Dualis Plus ND:Yag Laser SystemFotona D.D. · 2002
- Descendant · cites it directly · 200 of its ownK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- Descendant · 2 generations on · 194 of its ownK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- Descendant · 3 generations on · 166 of its ownK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
- Descendant · 4 generations on · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
- Descendant · 2 generations on · 83 of its ownK093162 Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii…Fotona D.D. · 2010
Showing 5 of 251 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 251 · See all- K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D. · 2005 · cites it directly200descendants
- K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008 · 2 generations on194descendants
- K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009 · 3 generations on166descendants
- K103455Spectra Laser SystemLutronic Corporation · 2011 · 4 generations on92descendants
- K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D. · 2010 · 2 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022839 | Fotona Dualis Plus ND:Yag Laser System | Fotona D.D. | 2002 | — |
| +1 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| +2 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| +3 | K083889 | Fotona QX ND:Yag/KTP Laser System Family | Fotona D.D. | 2009 | — |
| +4 | K103455 | Spectra Laser System | Lutronic Corporation | 2011 | — |
| +2 | K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at… | Fotona D.D. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 12 | 0 |
| 2017 | 17 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 14 | 0 |
| 2021 | 15 | 0 |
| 2022 | 25 | 0 |
| 2023 | 16 | 0 |
| 2024 | 26 | 0 |
| 2025 | 41 | 0 |
| 2026 | 23 | 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? (1)
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 |
|---|---|---|---|
| * | — | Altus Medical A-esthetic Nd:YAG Laser Named without a submission number |
What descends from it? (251)
See all 2512 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?
- Of its descendants, K050293 (Fotona D.D., 2005) has gone furthest, with 200 descendants of its own.
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?
The Fatona DUAZIS" Plus Nd:YAG laser system is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology: To effect stable long-tenii, or permanent, hair reduction in skin types I .- VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable…
Read the full statement (122 words)
The Fatona DUAZIS" Plus Nd:YAG laser system is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:
To effect stable long-tenii, or permanent, hair reduction in skin types I .- VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment reginicn.
For renioval of unwanted hair.
For coagulation and hemostasis of vascular lesions.
For incisiodescision of soft body tissue in deniiatology
For soft tissue general surgery applications - skin incision; tissue dissectioii; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022839: Fotona Dualis Plus ND:Yag 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/K022839
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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