510(k) · Cleared
ClearedThe MeDioStar NeXT Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asclepion Laser Technologies GmbH · GEX Powered Laser Surgical Instrument
Cleared on Mar 10, 2015 as substantially equivalent to K111851 (Asclepion Laser Technologies GmbH, 2011) and 1 other predicate after an 88-day review. Its family tree reaches back 20 generations to 1995. 32 later devices descend from it.
- Decided
- Mar 10, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K943450 (1995). 516 ancestors in all, the oldest K771218 (1978). 32 later devices descend from it, 4 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 1 generation backK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- This deviceK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- Descendant · cites it directly · 13 of its ownK180719 InMode Diolaze SystemInmode MD, Ltd. · 2018
- Descendant · cites it directly · 13 of its ownK152714 Quanta ForteQuanta System Spa · 2015
- Descendant · 2 generations on · 8 of its ownK191321 Primelase ExcellenceHigh Technology Products S.L.U · 2019
- Descendant · 2 generations on · 5 of its ownK172413 MT ONEM&T S.R.L. · 2017
- Descendant · 2 generations on · 4 of its ownK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 7 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 6 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 1 generation backK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- This deviceK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K180719InMode Diolaze SystemInmode MD, Ltd. · 2018 · cites it directly13descendants
- K152714Quanta ForteQuanta System Spa · 2015 · cites it directly13descendants
- K191321Primelase ExcellenceHigh Technology Products S.L.U · 2019 · 2 generations on8descendants
- K172413MT ONEM&T S.R.L. · 2017 · 2 generations on5descendants
- K192539Deka LuxeaEl.En Electronic Engineering Spa · 2019 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −7 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −6 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −3 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −1 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| 0 (this device) | K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015 | — |
| +1 | K180719 | InMode Diolaze System | Inmode MD, Ltd. | 2018 | — |
| +1 | K152714 | Quanta Forte | Quanta System Spa | 2015 | — |
| +2 | K191321 | Primelase Excellence | High Technology Products S.L.U | 2019 | — |
| +2 | K172413 | MT ONE | M&T S.R.L. | 2017 | — |
| +2 | K192539 | Deka Luxea | El.En Electronic Engineering Spa | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 8 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 25 | 0 |
| 1995 | 25 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 30 | 0 |
| 1999 | 26 | 0 |
| 2000 | 34 | 0 |
| 2001 | 34 | 0 |
| 2002 | 42 | 0 |
| 2003 | 47 | 0 |
| 2004 | 34 | 0 |
| 2005 | 28 | 0 |
| 2006 | 15 | 0 |
| 2007 | 16 | 0 |
| 2008 | 18 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K111851 | Mediostar NextSummary page 5…21 CFR 878.4810 Regulatory Class: Class II Product Code: GEX Equivalent Devices: MeDioStar NeXT K111851 Alma Lasers 755 nm Diode Module K140009 Device Description: The MeDioStar NeXT and the MeDioStar NeX… | 2011 |
| * | K140009 | Soprano Ice Multi-Application & Multi-Technology PlatformSummary page 5…egulatory Class: Class II Product Code: GEX Equivalent Devices: MeDioStar NeXT K111851 Alma Lasers 755 nm Diode Module K140009 Device Description: The MeDioStar NeXT and the MeDioStar NeXTPRO (The MeDioStar NeXT Family) are puls… | 2014 |
What descends from it? (32)
See all 324 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 9 companies; a new generation was cleared every 10 months on median.
- 26 of the 516 ancestors have a recall of any class.
- Of its descendants, K180719 (Inmode MD, Ltd., 2018) has gone furthest, with 13 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?
The MeDioStar NeXT Family laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar NeXT Family laser system is intended for the treatment of benign vascular lesions.
The MeDioStar NeXT Family laser system is intended for the treatment of benign pigmented lesions.
The MeDioStar NeXT Family laser system is intended for hair removal, permanent hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.
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/K143519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143519: The MeDioStar NeXT Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143519
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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