510(k) · Cleared
ClearedEllipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
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 Jul 7, 2015 as substantially equivalent to K140670 (Ellipse A/S, 2014) and 2 other predicates after a 95-day review. Its family tree reaches back 16 generations to 1995. 5 later devices descend from it.
- Decided
- Jul 7, 2015
- Review
- 95 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K943450 (1995). 226 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 2 generations backK081408 Ellipse MultiflexEllipse A/S · 2008
- 1 generation backK140670 Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S · 2014 · Recalled
- This deviceK150907 Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S · 2015
- Descendant · cites it directly · 4 of its ownK161162 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius…Ellipse A/S · 2016
- Descendant · cites it directly · 2 of its ownK192856 MT OneM&T S.R.L. · 2020
- Descendant · 2 generations on · 1 of its ownK203395 Platform treatment systemShanghai Apolo Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK240474 Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd · 2024
- Descendant · 2 generations on · 0 of its ownK180406 Ellipse YdunEllipse A/S · 2018
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 3 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 2 generations backK081408 Ellipse MultiflexEllipse A/S · 2008
- 1 generation backK140670 Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S · 2014 · Recalled
- This deviceK150907 Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S · 2015
Most influential descendants
Showing 5 of 5 · See all- K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S · 2016 · cites it directly4descendants
- K192856MT OneM&T S.R.L. · 2020 · cites it directly2descendants
- K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd · 2024 · 2 generations on0descendants
- K180406Ellipse YdunEllipse A/S · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −3 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −2 | K081408 | Ellipse Multiflex | Ellipse A/S | 2008 | — |
| −1 | K140670 | Ellipse I2PL+/Ellipse Multiflex+ | Ellipse A/S | 2014 | 1 |
| 0 (this device) | K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse… | Ellipse A/S | 2015 | — |
| +1 | K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse… | Ellipse A/S | 2016 | — |
| +1 | K192856 | MT One | M&T S.R.L. | 2020 | — |
| +2 | K203395 | Platform treatment system | Shanghai Apolo Medical Technology Co., Ltd. | 2022 | — |
| +2 | K240474 | Multi-function Platform Systems (BL-M10) | Shanghai Bele Medical Technology Co.,Ltd | 2024 | — |
| +2 | K180406 | Ellipse Ydun | Ellipse A/S | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 4 | 0 |
| 1993 | 9 | 0 |
| 1994 | 14 | 0 |
| 1995 | 13 | 0 |
| 1996 | 19 | 0 |
| 1997 | 21 | 0 |
| 1998 | 16 | 0 |
| 1999 | 10 | 0 |
| 2000 | 19 | 0 |
| 2001 | 20 | 0 |
| 2002 | 23 | 0 |
| 2003 | 10 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K140670 | Ellipse I2PL+/Ellipse Multiflex+Summary page 4…78.4810). Device classification: Class II Product code: GEX Predicate Devices: Predicate devices legally marketed Ellipse MultiFlex+ (K140670). TM to which Ellipse A/S claims Ellipse A/S substantial equivale… | 2014 |
| * | K122493 | GenesisplusSummary page 4…l and plastic surgery and in dermatology (per 21 CFR Part 878.4810)). Genesisplus Laser SystemTM (K122493) Cutera, Inc., 3240 Bayshore Blvd., Brisbane, CA94005, USA.… | 2013 |
| * | K033461 | Candela Vbeam Pulse Dye Laser SystemSummary page 4…in general and plastic surgery and in dermatology (per 21 CFR Part 878.4810)). Candela V-beamTM (K033461) Candela Corporation, 530 Boston Post Rd., Wayland, MA01778, USA.… | 2004 |
What descends from it? (5)
2 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 20 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 9 of the 226 ancestors have a recall of any class.
- Of its descendants, K161162 (Ellipse A/S, 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Nordlys system is intended to be used in dermatology, as tabled below: •Permanent Hair Reduction (defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime) (overall 600-950nm). •Treatment of Telangiectasias (530-750nm or 555-950nm). •Treatment of Port Wine Stains (530-750nm or 555-950nm). •Treatment of Benign Pigmented Lesions (eg Mottled…
Read the full statement (193 words)
Ellipse Nordlys system is intended to be used in dermatology, as tabled below:
•Permanent Hair Reduction (defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime) (overall 600-950nm).
•Treatment of Telangiectasias (530-750nm or 555-950nm).
•Treatment of Port Wine Stains (530-750nm or 555-950nm).
•Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffuse Redness) (530-750nm or 555-950nm).
•Treatment of Rosacea (530-750nm or 555-950nm).
•Treatment of Poikiloderma of Civatte (530-750nm or 555-950nm).
•Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).
•Treatment of Inflammatory Acne Vulgaris (530-750nm).
•Using Nd:YAG laser, (1064nm) (Ellipse MultiFlex+ system, only):
•Treatment of Leg vessels (0.1 -3.0mm diameter).
•Treatment of Benign Vascular Lesions
•Treatment of Venous Lakes
•Treatment of Port Wine Stains
•Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
•Treatment of benign cutaneous lesions, such as warts.
•Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including
- Matrixectomy.
- Periungal and subungal warts
- Plantar warts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150907: Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150907
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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