510(k) · Cleared

Cleared

Atrilaze Surgical Ablation System

K060680510(k) SpecialCleared Apr 11, 200627-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

Medical Cv, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Apr 11, 2006 as substantially equivalent to K040744 (Medical Cv, Inc., 2004) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1998. 3 later devices descend from it.

Decided: Apr 11, 2006
Review: 27 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K980668 (1998). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK980668 CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc. · 1998
3 generations backK011988 Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
2 generations backK013901 Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
1 generation backK052495 Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
This deviceK060680 Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
Descendant · cites it directly · 1 of its ownK081457 Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008
Descendant · cites it directly · 1 of its ownK061489 Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK082409 Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000…Endophotonix, Inc. · 2009

Most influential descendants

Showing 3 of 3 · See all

K081457Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008 · cites it directly1descendant
K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007 · cites it directly1descendant
K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc. · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K980668	CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790	Cryomedical Sciences, Inc.	1998	—
−3	K011988	Surgical Lightstic 180, Model 180 L, Model 180 C	Cardiofocus, Inc.	2001	—
−2	K013901	Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)	Cardiofocus, Inc.	2001	—
−1	K052495	Atrilaze Malleable Ablation Probe	Medical Cv, Inc.	2005	—
0 (this device)	K060680	Atrilaze Surgical Ablation System	Medical Cv, Inc.	2006	—
+1	K081457	Atrilaze Laser Ablation System	Medical Cv, Inc.	2008	—
+1	K061489	Atrilaze MI Surgical Ablation System	Medical Cv, Inc.	2007	—
+2	K082409	Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083…	Endophotonix, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0
2002	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0

FIG. 1 — Lineage of K060680, 1998–2009Source: 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
*	K040744	Atrilaze Soft Tissue Ablation System Summary page 2 …Page 2 of 2 Technological Comparison: The current Atrilaze Surgical Ablation System (K040744 & K052495) consists of a standalone surgical laser emitting 81Onm light and a disposable fiber optic delivery system (probe). The…	Medical Cv, Inc.	2004	—
*	K052495	Atrilaze Malleable Ablation Probe Summary page 2 …Page 2 of 2 Technological Comparison: The current Atrilaze Surgical Ablation System (K040744 & K052495) consists of a standalone surgical laser emitting 81Onm light and a disposable fiber optic delivery system (probe). The fiber opt…	Medical Cv, Inc.	2005	—

Also cleared against K040744: 2 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K081457	Atrilaze Laser Ablation System	Medical Cv, Inc.	2008	1
K061489	Atrilaze MI Surgical Ablation System	Medical Cv, Inc.	2007	1

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 8 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K081457 (Medical Cv, Inc., 2008) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K040744.

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 Medical CV AtrilazeTM Surgical Ablation System is indicated for delivery of 810nm or 1064nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K060680 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060680: Atrilaze Surgical Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060680

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