510(k) · Cleared
ClearedEllipse Ydun
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellipse A/S · GEX Powered Laser Surgical Instrument
Cleared on Mar 15, 2018 as substantially equivalent to K161162 (Ellipse A/S, 2016) after a 29-day review. Its family tree reaches back 19 generations to 1992.
- Decided
- Mar 15, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K910422 (1992). 349 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 19 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 15 generations between
- 3 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 2 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 1 generation backK161162 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius…Ellipse A/S · 2016
- This deviceK180406 Ellipse YdunEllipse A/S · 2018
Show all 19 generations
- Root · 19 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 18 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 17 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 16 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 15 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 14 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 13 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 12 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 11 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 10 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 9 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 8 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 7 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 6 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 5 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 4 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 3 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 2 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 1 generation backK161162 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius…Ellipse A/S · 2016
- This deviceK180406 Ellipse YdunEllipse A/S · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −18 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −17 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −16 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −15 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −14 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −13 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −12 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −11 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −10 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −9 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −8 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −7 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −6 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −5 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −4 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −3 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −2 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| −1 | K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse… | Ellipse A/S | 2016 | — |
| 0 (this device) | K180406 | Ellipse Ydun | Ellipse A/S | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 9 | 0 |
| 1992 | 3 | 0 |
| 1993 | 9 | 0 |
| 1994 | 17 | 0 |
| 1995 | 19 | 0 |
| 1996 | 23 | 0 |
| 1997 | 24 | 0 |
| 1998 | 22 | 0 |
| 1999 | 15 | 0 |
| 2000 | 25 | 0 |
| 2001 | 29 | 0 |
| 2002 | 32 | 0 |
| 2003 | 28 | 0 |
| 2004 | 15 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Summary page 4…Class II (per 21 CFR 870.1250). Product code: GEX Predicate Devices: Predicate device legally marketed Ellipse Nordlys with Frax 1550 (K161162) to which Ellipse A/S claims Ellipse A/S Agern Alle 11 substantial equivalence: DK-2970-Hørsholm, Denmark ===… | 2016 |
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?
- The line of descent spans 26 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 349 ancestors have a recall of any class.
- 1 other device also cites its predicate K161162.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
Ellipse Ydun system is intended to be used in dermatology, as tabled below:
* Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
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/K180406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180406: Ellipse Ydun.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180406
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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