510(k) · Cleared

Cleared

Endovascular Laser Vein System Kit

K112299510(k) TraditionalCleared Nov 3, 201185-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

Biolitec Medical Devices, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Nov 3, 2011 as substantially equivalent to K101712 (Biolitec, Inc., 2010) after an 85-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.

Decided: Nov 3, 2011
Review: 85 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K101712 (2010). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK101712 Endovascular Laer Vein System KitBiolitec, Inc. · 2010
This deviceK112299 Endovascular Laser Vein System KitBiolitec Medical Devices, Inc. · 2011
Descendant · cites it directly · 0 of its ownK130681 Endovascular Laser Venous System Kit with 2 Ring Radial Emitting FiberBiolitec Sia · 2014

Most influential descendants

Showing 1 of 1 · See all

K130681Endovascular Laser Venous System Kit with 2 Ring Radial Emitting FiberBiolitec Sia · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K101712	Endovascular Laer Vein System Kit	Biolitec, Inc.	2010	—
0 (this device)	K112299	Endovascular Laser Vein System Kit	Biolitec Medical Devices, Inc.	2011	—
+1	K130681	Endovascular Laser Venous System Kit with 2 Ring Radial Emitting Fiber	Biolitec Sia	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K112299, 2010–2014Source: 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

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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
*	K101712	Endovascular Laer Vein System Kit Summary page 1 …Fibers contain the following components: (i) radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire and is identical to that cleared under K1017 12. Performance Data The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSIIAAM…	Biolitec, Inc.	2010	—
*	—	Ceralas Diode Laser System (1470nm, 980 nm and 810 nm) with ELVeS Kit Named without a submission number			—
†	K924258	Megabeam Radial Emit Shape Fiber Optic Deliv Syst	Ceram Optec, Inc.	1994	—

Also cleared against K101712: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130681	Endovascular Laser Venous System Kit with 2 Ring Radial Emitting Fiber	Biolitec Sia	2014	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?

Its one ancestor has no recall.
Of its descendants, K130681 (Biolitec Sia, 2014) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K101712.

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?

For Endovascular Coagulation of the Greater Saphenous Vein of the Thigh in Patients with Superficial Vein Reflux.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112299 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112299: Endovascular Laser Vein System Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112299

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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