510(k) · Cleared
ClearedQuadrostar 532
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 20, 2006 after a 26-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 20, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK060457 Quadrostar 532Asclepion Laser Technologies GmbH · 2006
- Descendant · cites it directly · 4 of its ownK133297 Quadrostarprogreen, QuadrostarproyellowAsclepion Laser Technologies GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK261094 YellowStarAsclepion Laser Technologies GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK251432 OloEl.En S.P.A. · 2025
- Descendant · 2 generations on · 0 of its ownK203054 FlexSysGme German Medical Engineering GmbH · 2021
- Descendant · 2 generations on · 0 of its ownK172198 585Quanta System Spa · 2017
Most influential descendants
Showing 5 of 5 · See all- K133297Quadrostarprogreen, QuadrostarproyellowAsclepion Laser Technologies GmbH · 2014 · cites it directly4descendants
- K261094YellowStarAsclepion Laser Technologies GmbH · 2026 · 2 generations on0descendants
- K251432OloEl.En S.P.A. · 2025 · 2 generations on0descendants
- K203054FlexSysGme German Medical Engineering GmbH · 2021 · 2 generations on0descendants
- K172198585Quanta System Spa · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060457 | Quadrostar 532 | Asclepion Laser Technologies GmbH | 2006 | — |
| +1 | K133297 | Quadrostarprogreen, Quadrostarproyellow | Asclepion Laser Technologies GmbH | 2014 | — |
| +2 | K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026 | — |
| +2 | K251432 | Olo | El.En S.P.A. | 2025 | — |
| +2 | K203054 | FlexSys | Gme German Medical Engineering GmbH | 2021 | — |
| +2 | K172198 | 585 | Quanta System Spa | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | — | BeautyStar 532 Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133297 | Quadrostarprogreen, Quadrostarproyellow | 2014 | 4 |
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?
- Of its descendants, K133297 (Asclepion Laser Technologies GmbH, 2014) 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.
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 QuadroStar 532 Laser System is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060457 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060457: Quadrostar 532.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060457
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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