510(k) · Cleared

Cleared

Angiodynamics, Inc. Venacure 1470 Laser

K110225510(k) TraditionalCleared May 13, 2011108-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

AngioDynamics, Inc. · GEX Powered Laser Surgical Instrument

Cleared on May 13, 2011 as substantially equivalent to K082225 (Biolitec, Inc., 2008) after a 108-day review. Its family tree reaches back 2 generations to 2005.

Decided: May 13, 2011
Review: 108 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K043046 (2005). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

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 deviceK110225 Angiodynamics, Inc. Venacure 1470 LaserAngioDynamics, Inc. · 2011

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)	K110225	Angiodynamics, Inc. Venacure 1470 Laser	AngioDynamics, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0

FIG. 1 — Lineage of K110225, 2005–2011Source: 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K051995	FDA’s K051995 is Profemur Renaissance Hip Stem Our reading of the summary gave K051995, FDA’s number for Profemur Renaissance Hip Stem (Wrightmedicaltechnologyinc). Its FDA name has none of the distinctive words the summary uses for the device it names, “AngioDynamics Delta 15 and AngioDynamics Delta 30 Lasers”. Kept off the family tree.	Wrightmedicaltechnologyinc	2005	—
*	K082225	15W Ceralas D 1470NM Diode Laser, Model D1470 Summary page 1 …ially equivalent to the AngioDynamics Delta 15 and AngioDynamics Delta 30 Lasers, K(05 1995, and the Biolitec 15W Ceralas D 1470nm Diode Laser, K082225. 4. Device Description The purpose of this Traditional 5 10(k) is to notify FDA of the proposed new…	Biolitec, Inc.	2008	—

Also cleared against K082225: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 6 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
None of the 5 ancestors has a recall.
4 other devices also cite its predicate K082225.

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. 2011, this device’s year, is highlighted.

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?

The AngioDynamics, VenaCure 1470 Laser is indicated 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/K110225 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110225: Angiodynamics, Inc. Venacure 1470 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110225

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