510(k) · Cleared
ClearedFotona Dualis, Fotona Dualis Plus
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 Dec 27, 2001 after a 189-day review. The FDA summary names its predicate without a number. 237 later devices descend from it.
- Decided
- Dec 27, 2001
- Review
- 189 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
237 later devices descend from it, 4 citing it directly.
- This deviceK011939 Fotona Dualis, Fotona Dualis PlusFotona D.D. · 2001
- Descendant · cites it directly · 229 of its ownK020697 Depilase Twin Yag Laser SystemDepilase Group, Ltd. · 2002
- Descendant · 2 generations on · 126 of its ownK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- Descendant · 2 generations on · 104 of its ownK032218 Adept 1064/532/755 LaserAdept Medical Concepts · 2003
- Descendant · 3 generations on · 96 of its ownK083207 Ultrawave Iii EX 1320Quanta System Spa · 2008 · Recalled
- Descendant · 3 generations on · 73 of its ownK062369 Iridex Oculight TXIridex Corp · 2006
Showing 5 of 237 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 237 · See all- K020697Depilase Twin Yag Laser SystemDepilase Group, Ltd. · 2002 · cites it directly229descendants
- K032220Adept 1064/532 LaserAdept Medical Concepts · 2003 · 2 generations on126descendants
- K032218Adept 1064/532/755 LaserAdept Medical Concepts · 2003 · 2 generations on104descendants
- K083207Ultrawave Iii EX 1320Quanta System Spa · 2008 · 3 generations on96descendants
- K062369Iridex Oculight TXIridex Corp · 2006 · 3 generations on73descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011939 | Fotona Dualis, Fotona Dualis Plus | Fotona D.D. | 2001 | — |
| +1 | K020697 | Depilase Twin Yag Laser System | Depilase Group, Ltd. | 2002 | — |
| +2 | K032220 | Adept 1064/532 Laser | Adept Medical Concepts | 2003 | — |
| +2 | K032218 | Adept 1064/532/755 Laser | Adept Medical Concepts | 2003 | — |
| +3 | K083207 | Ultrawave Iii EX 1320 | Quanta System Spa | 2008 | 1 |
| +3 | K062369 | Iridex Oculight TX | Iridex Corp | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 10 | 0 |
| 2017 | 11 | 0 |
| 2018 | 10 | 0 |
| 2019 | 8 | 0 |
| 2020 | 17 | 0 |
| 2021 | 7 | 0 |
| 2022 | 23 | 0 |
| 2023 | 13 | 0 |
| 2024 | 26 | 0 |
| 2025 | 44 | 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? (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 |
|---|---|---|---|
| * | — | Coherent VersaPulse laser system Named without a submission number | |
| * | — | Laserscope Lyra laser system Named without a submission number | |
| * | — | other KTP (532 nm) lasers previously cleared for similar clinical applications Named without a submission number |
What descends from it? (237)
See all 2374 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, K020697 (Depilase Group, Ltd., 2002) has gone furthest, with 229 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 Fotona Dualis KTP (532 nm) Laser System and Accessories is intended for
incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft
tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous
tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus,
mucous membrane, lymph vessels and nodes, organs, and glands.
Dermatology :
The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion
size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
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/K011939 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011939: Fotona Dualis, Fotona Dualis Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011939
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026