510(k) · Cleared
ClearedMediostar Next
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 Jul 8, 2011 as substantially equivalent to K053628 (Lumenis, Inc., 2006) and 1 other predicate after a 9-day review. Its family tree reaches back 1 generation to 2005. 33 later devices descend from it.
- Decided
- Jul 8, 2011
- Review
- 9 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K050900 (2005). 2 ancestors in all. 33 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK050900 Mediostar XTAsclepion Laser Technologies GmbH · 2005
- This deviceK111851 Mediostar NextAsclepion Laser Technologies GmbH · 2011
- Descendant · cites it directly · 32 of its ownK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- Descendant · 2 generations on · 13 of its ownK180719 InMode Diolaze SystemInmode MD, Ltd. · 2018
- Descendant · 2 generations on · 13 of its ownK152714 Quanta ForteQuanta System Spa · 2015
- Descendant · 3 generations on · 8 of its ownK191321 Primelase ExcellenceHigh Technology Products S.L.U · 2019
- Descendant · 3 generations on · 5 of its ownK172413 MT ONEM&T S.R.L. · 2017
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015 · cites it directly32descendants
- K180719InMode Diolaze SystemInmode MD, Ltd. · 2018 · 2 generations on13descendants
- K152714Quanta ForteQuanta System Spa · 2015 · 2 generations on13descendants
- K191321Primelase ExcellenceHigh Technology Products S.L.U · 2019 · 3 generations on8descendants
- K172413MT ONEM&T S.R.L. · 2017 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050900 | Mediostar XT | Asclepion Laser Technologies GmbH | 2005 | — |
| 0 (this device) | K111851 | Mediostar Next | Asclepion Laser Technologies GmbH | 2011 | — |
| +1 | K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015 | — |
| +2 | K180719 | InMode Diolaze System | Inmode MD, Ltd. | 2018 | — |
| +2 | K152714 | Quanta Forte | Quanta System Spa | 2015 | — |
| +3 | K191321 | Primelase Excellence | High Technology Products S.L.U | 2019 | — |
| +3 | K172413 | MT ONE | M&T S.R.L. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K053628 | Lightsheer Duet Laser SystemSummary page 1…surgery and in dermatology 79-GEX 21 CFR 878.4810 Equivalent Devices: LightSheer Duet K053628 MeDioStar XT K050900 Device Description: The MeDioStar NeXT is a pulsed diode laser emitting… | 2006 |
| * | K050900 | Mediostar XTSummary page 1…79-GEX 21 CFR 878.4810 Equivalent Devices: LightSheer Duet K053628 MeDioStar XT K050900 Device Description: The MeDioStar NeXT is a pulsed diode laser emitting a wavelength of 800 -… | 2005 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143519 | The MeDioStar NeXT Family | 2015 | 32 |
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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar NeXT laser system is intended for the treatment of vascular lesions.
The MeDioStar NeXT laser system is intended for hair removal, permanent hair reduction and the treatment of pigmented lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111851: Mediostar Next.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111851
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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