510(k) · Cleared
ClearedLaser System Yellowstar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asclepion-Meditec AG · GEX Powered Laser Surgical Instrument
Cleared on Feb 26, 2002 as substantially equivalent to K932723 (Buckman Co., Inc., 1994) and 3 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1988. 9 later devices descend from it.
- Decided
- Feb 26, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K883541 (1988). 4 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK883541 Metalaser VasculaseMetatech Corp. · 1988
- This deviceK013940 Laser System YellowstarAsclepion-Meditec AG · 2002
- Descendant · cites it directly · 4 of its ownK133297 Quadrostarprogreen, QuadrostarproyellowAsclepion Laser Technologies GmbH · 2014
- Descendant · cites it directly · 3 of its ownK023899 Dual Yellow Laser, Model D10BNorseld Pty., Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK032397 Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd. · 2004
- Descendant · 2 generations on · 1 of its ownK132976 AdvatxAdvalight Aps · 2014
- Descendant · 2 generations on · 0 of its ownK261094 YellowStarAsclepion Laser Technologies GmbH · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K133297Quadrostarprogreen, QuadrostarproyellowAsclepion Laser Technologies GmbH · 2014 · cites it directly4descendants
- K023899Dual Yellow Laser, Model D10BNorseld Pty., Ltd. · 2003 · cites it directly3descendants
- K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd. · 2004 · cites it directly2descendants
- K132976AdvatxAdvalight Aps · 2014 · 2 generations on1descendant
- K261094YellowStarAsclepion Laser Technologies GmbH · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883541 | Metalaser Vasculase | Metatech Corp. | 1988 | — |
| 0 (this device) | K013940 | Laser System Yellowstar | Asclepion-Meditec AG | 2002 | — |
| +1 | K133297 | Quadrostarprogreen, Quadrostarproyellow | Asclepion Laser Technologies GmbH | 2014 | — |
| +1 | K023899 | Dual Yellow Laser, Model D10B | Norseld Pty., Ltd. | 2003 | — |
| +1 | K032397 | Dual Yellow Laser, Model Dual Yellow D10B | Norseld Pty., Ltd. | 2004 | — |
| +2 | K132976 | Advatx | Advalight Aps | 2014 | — |
| +2 | K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K932723 | Conbio Cub-D10 Copper Laser SystemSummary page 1…of vascular and pigmented lesions. The specifications of the YellowStar are the same as or very similar to those of legally marketed lasers such as the ConBio CuB-D10 (K932723, K942934) and Metatech Vasculase (K883541, K903883) 510(K) Submission LASER SYSTEM YellowStar Page 73 of 74 Perf… | 1994 |
| * | K942934 | Conbio Cub-D10 Cooper Laser SystemSummary page 1…ar and pigmented lesions. The specifications of the YellowStar are the same as or very similar to those of legally marketed lasers such as the ConBio CuB-D10 (K932723, K942934) and Metatech Vasculase (K883541, K903883) 510(K) Submission LASER SYSTEM YellowStar Page 73 of 74 Performance d… | 1994 |
| * | K883541 | Metalaser VasculaseSummary page 1…ecifications of the YellowStar are the same as or very similar to those of legally marketed lasers such as the ConBio CuB-D10 (K932723, K942934) and Metatech Vasculase (K883541, K903883) 510(K) Submission LASER SYSTEM YellowStar Page 73 of 74 Performance data: None. The specifications and… | 1988 |
| * | K903883 | Vasculase (R) Copper Vapor Laser Syst, Pigment LesSummary page 1…ons of the YellowStar are the same as or very similar to those of legally marketed lasers such as the ConBio CuB-D10 (K932723, K942934) and Metatech Vasculase (K883541, K903883) 510(K) Submission LASER SYSTEM YellowStar Page 73 of 74 Performance data: None. The specifications and intended… | 1990 |
What descends from it? (9)
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?
- None of the 4 ancestors has a recall.
- 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 YellowStar is intended for treatment of vascular and pigmented lesions.
The laser system YellowStar is restricted to sale to or use by licensed professionals in the United States.
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/K013940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013940: Laser System Yellowstar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013940
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026