510(k) · Cleared

Cleared

Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR

K013201510(k) TraditionalCleared Mar 18, 2002174-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

Cardiofocus, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Mar 18, 2002 as substantially equivalent to K001975 (Ceram Optec, Inc., 2000) after a 174-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.

Decided: Mar 18, 2002
Review: 174 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001975 (2000). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001975 Ceralas D10 810NM Laser, Model Ceralas D10-60Ceram Optec, Inc. · 2000
This deviceK013201 Cardiofocus Diode Laser System, Models 60R, 60NR, 30NRCardiofocus, Inc. · 2002
Descendant · cites it directly · 5 of its ownK040744 Atrilaze Soft Tissue Ablation SystemMedical Cv, Inc. · 2004
Descendant · 2 generations on · 4 of its ownK052495 Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
Descendant · 2 generations on · 3 of its ownK060680 Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
Descendant · 3 generations on · 1 of its ownK081457 Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008
Descendant · 2 generations on · 1 of its ownK061489 Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004high 1 (2004) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all

K040744Atrilaze Soft Tissue Ablation SystemMedical Cv, Inc. · 2004 · cites it directly5descendants
K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005 · 2 generations on4descendants
K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006 · 2 generations on3descendants
K081457Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008 · 3 generations on1descendant
K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001975	Ceralas D10 810NM Laser, Model Ceralas D10-60	Ceram Optec, Inc.	2000	—
0 (this device)	K013201	Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR	Cardiofocus, Inc.	2002	—
+1	K040744	Atrilaze Soft Tissue Ablation System	Medical Cv, Inc.	2004	—
+2	K052495	Atrilaze Malleable Ablation Probe	Medical Cv, Inc.	2005	—
+2	K060680	Atrilaze Surgical Ablation System	Medical Cv, Inc.	2006	—
+3	K081457	Atrilaze Laser Ablation System	Medical Cv, Inc.	2008	—
+2	K061489	Atrilaze MI Surgical Ablation System	Medical Cv, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2007	1	0
2008	1	0
2009	1	0

FIG. 1 — Lineage of K013201, 2000–2009Source: 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? (1)

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
*	K001975	Ceralas D10 810NM Laser, Model Ceralas D10-60 Summary page 1 …on Name: l.aser, Powered, Surgical Instrument. CFR ref: 878.4810, product Code GEX Predicate Devices: Ceralas Diode Laser System CeramOptec, Inc., East Longmeadow, MA K001975; S.E. 8-4-2000 Intended Use: The CardioFocus Laser Diode System is intended for the delivery of 980nm laser light to soft tissu…	Ceram Optec, Inc.	2000	—

Also cleared against K001975: 2 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K040744	Atrilaze Soft Tissue Ablation System	Medical Cv, Inc.	2004	5

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, K040744 (Medical Cv, Inc., 2004) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K001975.

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 CardioFocus Diode Laser System is intended for the delivery of 980nm laser light to soft tissue in contact or non-contact mode during surgical procedures including via endoscopes, introducers or catheters. 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/K013201 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013201: Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013201

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026