510(k) · Cleared
ClearedEllipse Multiflex
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 Oct 17, 2008 as substantially equivalent to K060448 (Lumenis, Ltd., 2006) and 3 other predicates after a 151-day review. Its family tree reaches back 14 generations to 1995. 7 later devices descend from it.
- Decided
- Oct 17, 2008
- Review
- 151 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K943450 (1995). 152 ancestors in all, the oldest K800617 (1980). 7 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- This deviceK081408 Ellipse MultiflexEllipse A/S · 2008
- 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 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- This deviceK081408 Ellipse MultiflexEllipse A/S · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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 |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −2 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −1 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| 0 (this device) | K081408 | Ellipse Multiflex | Ellipse A/S | 2008 | — |
| +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 |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 14 | 0 |
| 1997 | 17 | 0 |
| 1998 | 10 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 12 | 0 |
| 2002 | 14 | 0 |
| 2003 | 9 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K060448 | Lumenis One Family of Systems; Lumenis One.Summary page 1…CFR Part 878.48 10). Device classification: Class II. Product code: GEX Predicate devices legally Multi-Spot Nd: YAG (K060448) manufactured by marketed to which Ellipse Lumenis Inc., 2400 Condensa Street, Santa Clara, CA 9505 1,USA. A/S claims… | 2006 |
| * | K033946 | Lovely SystemSummary page 1…c surgery and equivalence: in dermatology (per 21 CFR Part 878.481 0)). Alma Harmony long pulsed Nd YA G (K033946) manufactured by MSq(M2) Ltd., 7 llaeshel St., P.O.B. 3021, Caesarea Industrial park,… | 2004 |
| * | K041879 | Palomar LUX1064 HandpieceSummary page 1…se in general and plastic surgery and in dermatology (per 21 CFR Part 878.48 10)). Lux] 064 (K041879) manufactured by Palomar Medical Technologies, Inc., 82 Cambridge Street,… | 2005 |
| * | K052688 | Ellipse Flex PPT, Model 9ESF7255Summary page 1…neral and plastic surgery and in dermatology (per 21 CFR Part 878.48 10)). Ellipse Flex PPT (K052688) manufactured by Ellipse A/S, Agern Alle 11, DK-2970 Hoersholm, Denmark, as far as… | 2005 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140670 | Ellipse I2PL+/Ellipse Multiflex+ | 2014 | 6 |
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 9 months on median.
- 6 of the 152 ancestors have a recall of any class.
- Of its descendants, K140670 (Ellipse A/S, 2014) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K060448.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 MultiFlex is intended for use in dermatology.
Ellipse MultiFlex used with IPL applicators(9APP7133, 7116, 7114, 7134, 7212, 7377, 7213):
* 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.
Ellipse MultiFlex used with Nd;YAG applicator(9APP7472):
* Treatment of leg vessels (0.1 - 3.0 mm diameter).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081408: Ellipse Multiflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081408
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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