510(k) · Cleared
ClearedFotona Dualis ND:Yag Laser System, Fotona Twinlight ND:Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mojca Valijavec · GEX Powered Laser Surgical Instrument
Cleared on Dec 6, 2001 as substantially equivalent to K010834 (Laserscope, 2001) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Dec 6, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003202 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK003202 Family of Altus Medical Coolglide Aesthetic Lasers, Models I & IIAltus Medical · 2001
- This deviceK013047 Fotona Dualis ND:Yag Laser System, Fotona Twinlight ND:Yag Laser…Mojca Valijavec · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003202 | Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II | Altus Medical | 2001 | — |
| 0 (this device) | K013047 | Fotona Dualis ND:Yag Laser System, Fotona Twinlight ND:Yag Laser System | Mojca Valijavec | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 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? (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 |
|---|---|---|---|
| * | K010834 | Lyra Series Surgical Laser System & AccessoriesSummary page 1…nce The family of Fotona DUALIS lasers shares the same general indications for use, and therefore is substantially equivalent to the currently marketed Laserscope Lyra (K010834) and to Altus Medical Aesthetic Nd:YAG Laser (K003202). 510(k) Submission: Family of Fotona DUALIS Nd:YAG Lasers Pagc 18 === Pa… | 2001 |
| * | K003202 | Family of Altus Medical Coolglide Aesthetic Lasers, Models I & IISummary page 1…e general indications for use, and therefore is substantially equivalent to the currently marketed Laserscope Lyra (K010834) and to Altus Medical Aesthetic Nd:YAG Laser (K003202). 510(k) Submission: Family of Fotona DUALIS Nd:YAG Lasers Pagc 18 Technologically, the predicate devices have s… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 7 other devices also cite its predicate K010834.
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 family of Fotona DUALIS Nd:YAG laser systems 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-term, or permanent, hair reduction in skin types I - VI through selective targeting of melanin in hair folliclcs. Permanent hair reduction is defined as a long-term stable…
Read the full statement (128 words)
The family of Fotona DUALIS Nd:YAG laser systems 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-term, or permanent, hair reduction in skin types I - VI through selective targeting of melanin in hair folliclcs. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a trcatment regimen.
. For rcmoval of unwanted hair.
. For coagulation and hemostasis of vascular lesions.
. For incision/excision of soft body tissue in dermatology
. For soft tissue general surgery applications - skin incision; tissue dissection; complete or partial resection of intcrnal organs, tumors, lesions; tissue ablation; vessel coagulation
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/K013047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013047: Fotona Dualis ND:Yag Laser System, Fotona Twinlight ND:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013047
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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