510(k) · Cleared
ClearedQuadrostarprogreen, Quadrostarproyellow
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 Jun 10, 2014 as substantially equivalent to K013940 (Asclepion-Meditec AG, 2002) and 1 other predicate after a 228-day review. Its family tree reaches back 2 generations to 1988. 4 later devices descend from it.
- Decided
- Jun 10, 2014
- Review
- 228 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K883541 (1988). 6 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK883541 Metalaser VasculaseMetatech Corp. · 1988
- 1 generation backK013940 Laser System YellowstarAsclepion-Meditec AG · 2002
- This deviceK133297 Quadrostarprogreen, QuadrostarproyellowAsclepion Laser Technologies GmbH · 2014
- Descendant · cites it directly · 0 of its ownK261094 YellowStarAsclepion Laser Technologies GmbH · 2026
- Descendant · cites it directly · 0 of its ownK251432 OloEl.En S.P.A. · 2025
- Descendant · cites it directly · 0 of its ownK203054 FlexSysGme German Medical Engineering GmbH · 2021
- Descendant · cites it directly · 0 of its ownK172198 585Quanta System Spa · 2017
Most influential descendants
Showing 4 of 4 · See all- K261094YellowStarAsclepion Laser Technologies GmbH · 2026 · cites it directly0descendants
- K251432OloEl.En S.P.A. · 2025 · cites it directly0descendants
- K203054FlexSysGme German Medical Engineering GmbH · 2021 · cites it directly0descendants
- K172198585Quanta System Spa · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883541 | Metalaser Vasculase | Metatech Corp. | 1988 | — |
| −1 | K013940 | Laser System Yellowstar | Asclepion-Meditec AG | 2002 | — |
| 0 (this device) | K133297 | Quadrostarprogreen, Quadrostarproyellow | Asclepion Laser Technologies GmbH | 2014 | — |
| +1 | K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026 | — |
| +1 | K251432 | Olo | El.En S.P.A. | 2025 | — |
| +1 | K203054 | FlexSys | Gme German Medical Engineering GmbH | 2021 | — |
| +1 | K172198 | 585 | Quanta System Spa | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K013940 | Laser System YellowstarSummary page 1…use in general and plastic surgery 79-GEX 21 CFR 878.4810 Equivalent Devices: K013940 YellowStar Asclepion-Meditec AG (Assignor of Asclepion Laser Technologies GmbH)… | 2002 |
| * | K060457 | Quadrostar 532Summary page 1…ivalent Devices: K013940 YellowStar Asclepion-Meditec AG (Assignor of Asclepion Laser Technologies GmbH) K060457 QuadroStar 532 Asclepion Laser Technologies GmbH Device Description: The QuadroStarPRO Laser system is a laser Cl… | 2006 |
What descends from it? (4)
4 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 26 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K261094 (Asclepion Laser Technologies GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K013940.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 QuadroStarPROYELLOW (wavelength: 577nm) is intended for treatment of benign vascular and benign pigmented lesions.
The QuadroStarPROGREEN (wavelength: 532nm) is intended for vaporisation and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133297: Quadrostarprogreen, Quadrostarproyellow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133297
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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