510(k) · Cleared
ClearedEllipse Light SPT
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 Feb 24, 2005 as substantially equivalent to K024093 (Lumenis, Ltd., 2003) and 5 other predicates after a 92-day review. Its family tree reaches back 7 generations to 1992. 25 later devices descend from it.
- Decided
- Feb 24, 2005
- Review
- 92 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K910422 (1992). 54 ancestors in all, the oldest K892514 (1990). 25 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 2 generations backK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- 1 generation backK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
- This deviceK043255 Ellipse Light SPTDanish Dermatologic Development A/S · 2005
- Descendant · cites it directly · 23 of its ownK052688 Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
- Descendant · cites it directly · 12 of its ownK060516 Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
- Descendant · 2 generations on · 8 of its ownK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
- Descendant · 2 generations on · 7 of its ownK081408 Ellipse MultiflexEllipse A/S · 2008
- Descendant · 3 generations on · 6 of its ownK173692 D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005 · cites it directly23descendants
- K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006 · cites it directly12descendants
- K112669Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012 · 2 generations on8descendants
- K081408Ellipse MultiflexEllipse A/S · 2008 · 2 generations on7descendants
- K173692D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −6 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −4 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −3 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −2 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| −1 | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… | Lumenis, Ltd. | 2003 | — |
| 0 (this device) | K043255 | Ellipse Light SPT | Danish Dermatologic Development A/S | 2005 | — |
| +1 | K052688 | Ellipse Flex PPT, Model 9ESF7255 | Danish Dermatologic Development A/S | 2005 | — |
| +1 | K060516 | Ellipse 12PL, Model 9ESL7228 | Danish Dermatologic Development A/S | 2006 | — |
| +2 | K112669 | Tattoostar Effect Y | Asclepion Laser Technologies GmbH | 2012 | — |
| +2 | K081408 | Ellipse Multiflex | Ellipse A/S | 2008 | — |
| +3 | K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018 | — |
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 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (6)
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 |
|---|---|---|---|
| * | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Summary page 1…. Device classification: Class IL. Product code: GEX Predicate devices legally IPL T M Quantum (K024093; K020839) manufactured by marketed to which DDD Lumenis Inc., 2400 Condensa Street, Santa Clara, CA 9505… | 2003 |
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…classification: Class IL. Product code: GEX Predicate devices legally IPL T M Quantum (K024093; K020839) manufactured by marketed to which DDD Lumenis Inc., 2400 Condensa Street, Santa Clara, CA 9505 1, tJSA.… | 2002 |
| * | K030897 | SkinstationSummary page 2…Quantum Skin Stationf M EsteLuxTh 510(k) reference Current submission K024093; K020839 K030897 K020453 Technology/ Intense Pulsed Light Intense Pulsed Light Intense P… | 2003 |
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 1…and plastic surgery and in dermatology (per 21 CFR Part 878.48 10)). EsteLux T~(K020453) manufactured by Palomar Medical Technologies, Inc., 82 Cambridge Street, Burlington… | 2002 |
| * | K991935 | Epilight Hair Removal System, Photoderm HR SystemSummary page 4…lent to the IPLTM Quantum (predicate device cleared in K024093, K020839), SkinStationTM (predicate device cleared in K030897), and EsteLuxTM (predicate device cleared in K991935, K984110). Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatolog… | 2000 |
| * | K984110 | Laserscope CoolspotSummary page 4…he IPLTM Quantum (predicate device cleared in K024093, K020839), SkinStationTM (predicate device cleared in K030897), and EsteLuxTM (predicate device cleared in K991935, K984110). Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatologic Develo… | 1998 |
What descends from it? (25)
See all 253 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 13 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 54 ancestors has a recall of any class.
- Of its descendants, K052688 (Danish Dermatologic Development A/S, 2005) has gone furthest, with 23 descendants of its own.
- 4 other devices also cite its predicate K024093.
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 Intended Use for Ellipse 12PL is:
Ellipse 12 PL 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 (diffuse redness).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043255: Ellipse Light SPT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043255
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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