510(k) · Cleared
ClearedMedical Diode Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Gigaa Optronics Technology Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Apr 7, 2017 as substantially equivalent to K082225 (Biolitec, Inc., 2008) after a 403-day review. Its family tree reaches back 2 generations to 2005. 6 later devices descend from it.
- Decided
- Apr 7, 2017
- Review
- 403 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K043046 (2005). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK043046 Cooltouch, Model CT3SNew Star Lasers, Inc. · 2005
- 1 generation backK082225 15W Ceralas D 1470NM Diode Laser, Model D1470Biolitec, Inc. · 2008
- This deviceK160549 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK211977 Medical Diode Laser SystemsWuhan Dimed Laser Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK241930 VeincareWontech Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK252564 Medical Diode Laser Systems (VeinCure)Baoding Te'Anzhou Electronic Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251288 VeincareWontech Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K211977Medical Diode Laser SystemsWuhan Dimed Laser Technology Co., Ltd. · 2021 · cites it directly3descendants
- K241930VeincareWontech Co., Ltd. · 2024 · cites it directly1descendant
- K252564Medical Diode Laser Systems (VeinCure)Baoding Te'Anzhou Electronic Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K251288VeincareWontech Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K043046 | Cooltouch, Model CT3S | New Star Lasers, Inc. | 2005 | — |
| −1 | K082225 | 15W Ceralas D 1470NM Diode Laser, Model D1470 | Biolitec, Inc. | 2008 | — |
| 0 (this device) | K160549 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2017 | — |
| +1 | K211977 | Medical Diode Laser Systems | Wuhan Dimed Laser Technology Co., Ltd. | 2021 | — |
| +1 | K241930 | Veincare | Wontech Co., Ltd. | 2024 | — |
| +2 | K252564 | Medical Diode Laser Systems (VeinCure) | Baoding Te'Anzhou Electronic Technology Co., Ltd. | 2025 | — |
| +2 | K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems… | Wuhan Dimed Laser Technology Co., Ltd. | 2025 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K082225 | 15W Ceralas D 1470NM Diode Laser, Model D1470Summary page 4…edical diode laser systems Model: VELASⅡ-15D Classification Panel: General & Plastic Surgery Product Code: GEX Device Classification: Class II 4. The Predicate Devices K082225 15W Ceralas D 1470nm Diode Laser, D1470 5. Device Description Medical diode laser systems are a kind of laser with semiconducto… | 2008 |
| † | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and… | 2013 |
What descends from it? (6)
2 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 12 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K211977 (Wuhan Dimed Laser Technology Co., Ltd., 2021) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K082225.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 “VELASII-15D” is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
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/K160549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160549: Medical Diode Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160549
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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