510(k) · Cleared
ClearedEllipse 12PL, Model 9ESL7228
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Danish Dermatologic Development A/S · GEX Powered Laser Surgical Instrument
Cleared on May 15, 2006 as substantially equivalent to K043255 (Danish Dermatologic Development A/S, 2005) and 1 other predicate after a 77-day review. Its family tree reaches back 9 generations to 1992. 12 later devices descend from it.
- Decided
- May 15, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K910422 (1992). 61 ancestors in all, the oldest K892514 (1990). 12 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
- 2 generations backK043255 Ellipse Light SPTDanish Dermatologic Development A/S · 2005
- 1 generation backK052688 Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
- This deviceK060516 Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
- Descendant · cites it directly · 6 of its ownK140670 Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S · 2014 · Recalled
- Descendant · 2 generations on · 5 of its ownK150907 Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S · 2015
- Descendant · 3 generations on · 4 of its ownK161162 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius…Ellipse A/S · 2016
- Descendant · 3 generations on · 2 of its ownK192856 MT OneM&T S.R.L. · 2020
- Descendant · 4 generations on · 1 of its ownK203395 Platform treatment systemShanghai Apolo Medical Technology Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- 3 generations backK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
- 2 generations backK043255 Ellipse Light SPTDanish Dermatologic Development A/S · 2005
- 1 generation backK052688 Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
- This deviceK060516 Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S · 2014 · cites it directly6descendants
- K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S · 2015 · 2 generations on5descendants
- K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S · 2016 · 3 generations on4descendants
- K192856MT OneM&T S.R.L. · 2020 · 3 generations on2descendants
- K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| −3 | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… | Lumenis, Ltd. | 2003 | — |
| −2 | K043255 | Ellipse Light SPT | Danish Dermatologic Development A/S | 2005 | — |
| −1 | K052688 | Ellipse Flex PPT, Model 9ESF7255 | Danish Dermatologic Development A/S | 2005 | — |
| 0 (this device) | K060516 | Ellipse 12PL, Model 9ESL7228 | Danish Dermatologic Development A/S | 2006 | — |
| +1 | K140670 | Ellipse I2PL+/Ellipse Multiflex+ | Ellipse A/S | 2014 | 1 |
| +2 | K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse… | Ellipse A/S | 2015 | — |
| +3 | K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse… | Ellipse A/S | 2016 | — |
| +3 | K192856 | MT One | M&T S.R.L. | 2020 | — |
| +4 | K203395 | Platform treatment system | Shanghai Apolo Medical Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K043255 | Ellipse Light SPTSummary page 1…Part 878.48 10). Device classification: Class IL. Product code: GEX Predicate devices legally Ellipse I 2 PL (K043255) manufactured by Danish Dermatologic marketed to which DDD Development AIS, Agem Alle 11, DK-2970 Hoershoim, D… | 2005 |
| * | K052688 | Ellipse Flex PPT, Model 9ESF7255Summary page 1…and plastic surgery and in dermatology (per 21 CFR Part 878.48 10)). Ellipse Flex PPT (K052688) manufactured by Danish Dermatologic Development A/S, Agemn Alle 1 1, DK-2970 Hoershoim,… | 2005 |
What descends from it? (12)
See all 125 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 14 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 61 ancestors have a recall of any class.
- Of its descendants, K140670 (Ellipse A/S, 2014) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K043255.
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?
Ellipse I 2PL is intended for use in dermatology:
* Hair removal (permanent hair reduction).
* Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains).
* Treatment of inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060516 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060516: Ellipse 12PL, Model 9ESL7228.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060516
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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