510(k) · Cleared
ClearedFrax 1550 for Ellipse 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 Sep 16, 2016 as substantially equivalent to K150907 (Ellipse A/S, 2015) and 4 other predicates after a 144-day review. Its family tree reaches back 18 generations to 1992. 4 later devices descend from it.
- Decided
- Sep 16, 2016
- Review
- 144 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K910422 (1992). 348 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 14 generations between
- 3 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 2 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 1 generation backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- This deviceK161162 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 · cites it directly · 0 of its ownK180406 Ellipse YdunEllipse A/S · 2018
Show all 18 generations
- Root · 18 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 17 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 16 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 15 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 14 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 13 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 12 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 11 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 10 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 9 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 8 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 7 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 6 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 5 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 4 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 3 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 2 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 1 generation backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- This deviceK161162 Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius…Ellipse A/S · 2016
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −17 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −16 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −15 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −14 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −13 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −12 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −11 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −10 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −9 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −8 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −7 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −6 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −5 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −4 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −3 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −2 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −1 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| 0 (this device) | 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 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Summary page 5…r. Laser surgical instrument for use in general and plastic surgery and in dermatology (per 21 CFR Part 878.4810). Class II (per 21 CFR 870.1250). GEX Ellipse Nordlys (K150907) Ellipse A/S Agern Alle 11 DK-2970-Horsholm, Denmark Palomar Icon Aesthetic System (K142376) Cynosure Inc. 5 Carlisle Road Wes… | 2015 |
| * | K142376 | Palomar Icon Aesthetic SystemSummary page 5…1 CFR Part 878.4810). Class II (per 21 CFR 870.1250). GEX Ellipse Nordlys (K150907) Ellipse A/S Agern Alle 11 DK-2970-Horsholm, Denmark Palomar Icon Aesthetic System (K142376) Cynosure Inc. 5 Carlisle Road Westford, MA 01886, USA Fraxel Dual (K130193) Solta medical, Inc. 25881 Industrial Blvd. Haywa… | 2014 |
| * | K130193 | Fraxel Dual 1550/1927 Laser SystemSummary page 5…50907) Ellipse A/S Agern Alle 11 DK-2970-Horsholm, Denmark Palomar Icon Aesthetic System (K142376) Cynosure Inc. 5 Carlisle Road Westford, MA 01886, USA Fraxel Dual (K130193) Solta medical, Inc. 25881 Industrial Blvd. Hayward, CA 94545, USA Page | of 4 Lutronic Mosaic (K080932) Lutron… | 2013 |
| * | K080932 | Mosaic Laser SystemSummary page 6…sle Road Westford, MA 01886, USA Fraxel Dual (K130193) Solta medical, Inc. 25881 Industrial Blvd. Hayward, CA 94545, USA Page | of 4 Lutronic Mosaic (K080932) Lutronic Coorporation #403-2,3,4, Ilsan Technotown 1141-1Baeksok-Dong, Ilsan-Gu Goyang-Si, Gyeonggi-Do, 410-722 Republic of Kor… | 2008 |
| * | K130028 | Resurfx 1565NM Laser ModuleSummary page 6…nic Mosaic (K080932) Lutronic Coorporation #403-2,3,4, Ilsan Technotown 1141-1Baeksok-Dong, Ilsan-Gu Goyang-Si, Gyeonggi-Do, 410-722 Republic of Korea Lumenis ResurFX (K130028) Lumenis Ltd. 31 Haavoda St. Binyamina, IL 30500, USA Description of Ellipse Nordlys with associated applicators (hand pieces… | 2013 |
What descends from it? (4)
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 24 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 348 ancestors have a recall of any class.
- Of its descendants, K192856 (M&T S.R.L., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K150907.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 (238 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, (1064 nm):
• Treatment of Leg vessels (0.1 -3.0 mm 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.
Using Frax 1550 Laser, (1550 nm):
• The Frax 1550 nm laser 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/K161162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161162: Frax 1550 for 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 6, 2026. https://510kreport.com/device/K161162
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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