510(k) Report

510(k) · Cleared

Cleared

Modification to Vnus Closure System

K003092510(k) SpecialCleared Dec 18, 200076-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vnus Medical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 18, 2000 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 736 later devices descend from it.

Decided
Dec 18, 2000
Review
76 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

736 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2003: 6 descendants cleared2005: 4 descendants cleared2002: 2 descendants cleared2004: 5 descendants cleared2007: 10 descendants cleared2006: 5 descendants cleared2016: 42 descendants cleared2014: 31 descendants cleared2024: 77 descendants cleared2023: 47 descendants cleared2018: 37 descendants cleared2021: 33 descendants cleared2008: 21 descendants cleared2010: 21 descendants cleared2025: 92 descendants cleared2009: 17 descendants cleared2019: 26 descendants cleared2011: 17 descendants cleared2026: 53 descendants cleared2012: 17 descendants cleared2015: 25 descendants cleared2017: 36 descendants cleared2020: 40 descendants cleared2022: 51 descendants cleared2013: 21 descendants cleared200020052010201520202025
  1. This deviceK003092 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2000
  2. Descendant · cites it directly · 714 of its ownK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
  3. Descendant · 2 generations on · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
  4. Descendant · 3 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
  5. Descendant · 4 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
  6. Descendant · 5 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005

Showing 5 of 736 descendants. See all descendants

Descendants cleared per year

2002: 22003: 62004: 52005: 42006: 52007: 102008: 212009: 172010: 212011: 172012: 172013: 212014: 312015: 252016: 422017: 362018: 372019: 262020: 402021: 332022: 512023: 472024: 772025: 922026: 53
2002high 92 (2025) · low 2 (2002)2026

Most influential descendants

Showing 5 of 736 · See all
  • K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002 · cites it directly714descendants
  • K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · 2 generations on695descendants
  • K030186Polris LVSyneron Medical, Ltd. · 2003 · 3 generations on680descendants
  • K031671Polaris WRSyneron Medical, Ltd. · 2003 · 4 generations on678descendants
  • K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 5 generations on476descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003092Modification to Vnus Closure SystemVnus Medical Technologies, Inc.2000—
+1K012398Diomed 15 Diode LaserDiomed, Ltd.2002—
+2K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D…Dornier Medtech America, Inc.2002—
+3K030186Polris LVSyneron Medical, Ltd.2003—
+4K031671Polaris WRSyneron Medical, Ltd.2003—
+5K051214Aluma Skin Renewal SystemLumenis, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200360
200450
200540
200650
2007100
2008210
2009170
2010210
2011170
2012170
2013210
2014310
2015250
2016420
2017360
2018370
2019260
2020400
2021330
2022510
2023470
2024770
2025920
2026530
FIG. 1 — Lineage of K003092, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (736)

See all 736

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012398Diomed 15 Diode LaserDiomed, Ltd.2002714
K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc.200321
K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc.200410
K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046
K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc.20055
K023624SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc.20032

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, K012398 (Diomed, Ltd., 2002) has gone furthest, with 714 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

More from Vnus Medical Technologies, Inc.

9 FDA decisions under this applicant name. See the company

  • K082890Vnus Closurefast Intravascular Catheter, Models CF7-7-60-2, CF7-7-100-2Vnus Medical Technologies, Inc. · 2008
  • K061373Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc. · 20062 recalls
  • K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX = 10, 20, 30 & 40)Vnus Medical Technologies, Inc. · 2005
  • K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
  • K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc. · 2004

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The GEI category page

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https://510kreport.com/device/K003092 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003092: Modification to Vnus Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003092

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026