510(k) · Cleared
ClearedVeincare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wontech Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Nov 14, 2024 as substantially equivalent to K181632 (Quanta System Spa, 2018) and 1 other predicate after a 136-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Nov 14, 2024
- Review
- 136 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K043046 (2005). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK043046 Cooltouch, Model CT3SNew Star Lasers, Inc. · 2005
- 2 generations backK082225 15W Ceralas D 1470NM Diode Laser, Model D1470Biolitec, Inc. · 2008
- 1 generation backK160549 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2017
- This deviceK241930 VeincareWontech Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK251288 VeincareWontech Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251288VeincareWontech Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K043046 | Cooltouch, Model CT3S | New Star Lasers, Inc. | 2005 | — |
| −2 | K082225 | 15W Ceralas D 1470NM Diode Laser, Model D1470 | Biolitec, Inc. | 2008 | — |
| −1 | K160549 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2017 | — |
| 0 (this device) | K241930 | Veincare | Wontech Co., Ltd. | 2024 | — |
| +1 | K251288 | Veincare | Wontech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K181632 | Venacure 1470 ProSummary page 5…R 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device 1 ⚫ 510(k) Number: K181632 ⚫ Applicant: Quanta System Spa Page 1 /… | 2018 |
| * | K160549 | Medical Diode Laser SystemsSummary page 6…ermatology ⚫ Trade Name: VenaCure 1470 Pro Predicate device 2 ⚫ 510(k) Number: K160549 ⚫ Applicant: Wuhan Gigaa Optronics Technology Co., Ltd. ⚫ Classificatio… | 2017 |
| † | K232106 | Air Gap Fiber | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251288 | Veincare | 2025 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K251288 (Wontech Co., Ltd., 2025) has gone furthest, with 0 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. 2024, 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?
Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241930: Veincare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241930
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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