510(k) · Cleared

Cleared

Vascular Solutions Vari-Lase Endovenous Laser Console

K033237510(k) TraditionalCleared Nov 20, 200345-day reviewClass II21 CFR 878.4810

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

Vascular Solutions, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Nov 20, 2003 as substantially equivalent to K023543 (Diomed, Inc., 2002) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1999. 133 later devices descend from it.

Decided: Nov 20, 2003
Review: 45 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K991659 (1999). 2 ancestors in all. 133 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK991659 Uni-Laser 425P Diode Laser System & AccessoriesMedart Corp. · 1999
This deviceK033237 Vascular Solutions Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc. · 2003
Descendant · cites it directly · 132 of its ownK062822 Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc. · 2006
Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Descendant · 3 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 4 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014

Showing 5 of 133 descendants. See all descendants

Descendants cleared per year

2006high 18 (2022) · low 0 (2012)2026

Most influential descendants

Showing 5 of 133 · See all

K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc. · 2006 · cites it directly132descendants
K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 3 generations on112descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 4 generations on70descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991659	Uni-Laser 425P Diode Laser System & Accessories	Medart Corp.	1999	—
0 (this device)	K033237	Vascular Solutions Vari-Lase Endovenous Laser Console	Vascular Solutions, Inc.	2003	—
+1	K062822	Vari-Lase Endovenous Laser Console, Model 7500	Vascular Solutions, Inc.	2006	—
+2	K070388	Profile Multi-Platform System	Sciton, Inc	2007	—
+3	K081352	Profile Multi-Platform System	Sciton, Inc	2008	—
+3	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+4	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	7	0
2009	2	0
2010	4	0
2011	1	0
2014	3	0
2015	6	0
2016	1	0
2017	4	0
2018	9	0
2019	7	0
2020	11	0
2021	9	0
2022	18	0
2023	9	0
2024	14	0
2025	15	0
2026	11	0

FIG. 1 — Lineage of K033237, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K023543	Evlt Kit and D15PLUS and D30PLUS Diode Summary page 1 …u 2.22 Spedfication For Diagnostic And Therapeutic L a m Equipment Prcdicate Devices: Diomrd 15/30 Plus Diomrd. Inc. (IC023543) Medart 425P/426Lase2 Consoles (K99i659) Conclusions: The V.4RI-LASE…	Diomed, Inc.	2002	—
*	K991659	Uni-Laser 425P Diode Laser System & Accessories	Medart Corp.	1999	—

Also cleared against K023543: 7 other devices →

What descends from it? (133)

See all 133

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

Number	Device	Applicant	Decided	Descendants
K062822	Vari-Lase Endovenous Laser Console, Model 7500	Vascular Solutions, Inc.	2006	132
K080104	Vari-Lase Endovenous Laser Console, Model 7542	Vascular Solutions, Inc.	2008	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?

None of the 2 ancestors has a recall.
Of its descendants, K062822 (Vascular Solutions, Inc., 2006) has gone furthest, with 132 descendants of its own.
7 other devices also cite its predicate K023543.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)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?

VARI-LASE is indcated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033237 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033237: Vascular Solutions Vari-Lase Endovenous Laser Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033237

Report an extraction error

Are you the manufacturer?

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