510(k) · Cleared

Recalled · Class II · 2022

Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System

K053087510(k) TraditionalCleared Mar 1, 2006119-day reviewClass II21 CFR 878.4810Recalls 5

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

Biotex, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Mar 1, 2006 as substantially equivalent to K010041 (Surgical Laser Technologies, Inc., 2001) and 1 other predicate after a 119-day review. Its family tree reaches back 1 generation to 1997. 2 of the 36 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it. It has been recalled 5 times.

Decided: Mar 1, 2006
Review: 119 days
Class: Class II
Product code: GEX
Recalls: 5
Predicates: 2

Its longest line of descent runs back 1 generation to K963081 (1997). 2 ancestors in all. 33 later devices descend from it, 4 citing it directly. 2 of the 36 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK963081 Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for…Indigo Medical, Inc. · 1997
This deviceK053087 Visualase Cooled Laser Applicator System, Laser Diffusing Fiber…Biotex, Inc. · 2006
Descendant · cites it directly · 26 of its ownK071328 Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · Recalled
Descendant · 2 generations on · 22 of its ownK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
Descendant · 3 generations on · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
Descendant · 4 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
Descendant · 4 generations on · 19 of its ownK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2007high 5 (2017) · low 0 (2010)2026

Class I recalls in this family

K143457 NeuroBlate System5 generations on · 2015
K171255 Monteris Medical NeuroBlate System5 generations on · 2017

Most influential descendants

Showing 5 of 33 · See all

K071328Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · cites it directly26descendants
K081509Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009 · 2 generations on22descendants
K120561Neuroblate SystemMonteris Medical, Inc. · 2013 · 3 generations on21descendants
K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · 4 generations on19descendants
K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · 4 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963081	Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General…	Indigo Medical, Inc.	1997	—
0 (this device)	K053087	Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling…	Biotex, Inc.	2006	—
+1	K071328	Visualase Thermal Therapy System	Biotex, Inc.	2007	1
+2	K081509	Monteris Medical Autolitt Laser Probe	Monteris Medical,	2009	—
+3	K120561	Neuroblate System	Monteris Medical, Inc.	2013	1
+4	K131955	Neuroblate (TM) System	Monteris Medical, Inc.	2013	2
+4	K131278	Monteris Medical Neuroblate System	Monteris Medical, Inc.	2013	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0
2013	3	0
2014	1	0
2015	1	1
2016	2	0
2017	5	1
2018	1	0
2019	1	0
2020	2	0
2021	1	0
2022	3	0
2023	3	0
2024	1	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K053087, 1997–2026Source: 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.

2 devices in this family have a Class I recall. 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
*	K010041	SLT Diffuser Fiber Summary page 1 …Bare tip laser fiber or probe Classification: Accessory to powered surgical laser instrument Predicate Device SLT Diffuser TM Fiber (K010041) Indigo Bare-Tip Tm Fiberoptic (K963081) Description of Device The VCLAS family consists of three components, the LDF, CC…	Surgical Laser Technologies, Inc.	2001	—
*	K963081	Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological… Summary page 1 …Classification: Accessory to powered surgical laser instrument Predicate Device SLT Diffuser TM Fiber (K010041) Indigo Bare-Tip Tm Fiberoptic (K963081) Description of Device The VCLAS family consists of three components, the LDF, CCS, and BTF. The LDF and BTF transmit laser ener…	Indigo Medical, Inc.	1997	—

Also cleared against K010041: 2 other devices →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K071328	Visualase Thermal Therapy System	Biotex, Inc.	2007	26
K151569	Tranberg CLS Laser Fiber	Clinical Laserthermia Systems, AB	2016	2
K230460	Laser Thermal Therapy Kit	Elesta S.P.A	2023	1
K202953	Aurolase Therapy, Laser Delivery Device (LDD)	Nanospectra Biosciences, Inc.	2022	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 14, 2022	Class II	Z-0244-2023	Nonconforming Material/Component	Due to a defect in the outer pouch sterile seal
Mar 23, 2018	Class II	Z-2501-2018	Equipment maintenance	Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test equipment, which can lead to the…
Jul 27, 2017	Class II	Z-0025-2018	Process design	The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
Jun 7, 2017	Class II	Z-2755-2017	Component design/selection	Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA…
May 9, 2016	Class II	Z-1672-2016	Labeling design	Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K071328 (Biotex, Inc., 2007) has gone furthest, with 26 descendants of its own.
2 other devices also cite its predicate K010041.

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?

The Visualase Cooled Laser Applicator System (VCLAS) is comprised of a Laser Diffusing Fiber (LDF), a Cooling Catheter System (CCS), and a Bare Tip Fiber (BTF). The Laser Diffusing Fiber (LDF) and Cooling Catheter System (CCS) are indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial…

Read the full statement (169 words)

The Visualase Cooled Laser Applicator System (VCLAS) is comprised of a Laser Diffusing Fiber (LDF), a Cooling Catheter System (CCS), and a Bare Tip Fiber (BTF).

The Laser Diffusing Fiber (LDF) and Cooling Catheter System (CCS) are indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.

The Bare Tip Fiber (BTF) is intended for use in vaporization, cutting, ablation and coagulation of soft tissues with or without scopes or handpieces, for contact or non-contact surgery in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053087 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053087: Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053087

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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