510(k) · Cleared

Cleared

Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160

K062210510(k) TraditionalCleared Sep 25, 200655-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

New Star Lasers, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Sep 25, 2006 after a 55-day review. The FDA summary names its predicate without a number. 224 later devices descend from it.

Decided: Sep 25, 2006
Review: 55 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

224 later devices descend from it, 3 citing it directly.

This deviceK062210 Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160New Star Lasers, Inc. · 2006
Descendant · cites it directly · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Descendant · 2 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Descendant · 2 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
Descendant · cites it directly · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Descendant · cites it directly · 128 of its ownK082225 15W Ceralas D 1470NM Diode Laser, Model D1470Biolitec, Inc. · 2008

Showing 5 of 224 descendants. See all descendants

Descendants cleared per year

2007high 30 (2025) · low 1 (2007)2026

Most influential descendants

Showing 5 of 224 · See all

K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · cites it directly202descendants
K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 2 generations on192descendants
K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 2 generations on177descendants
K070388Profile Multi-Platform SystemSciton, Inc · 2007 · cites it directly129descendants
K08222515W Ceralas D 1470NM Diode Laser, Model D1470Biolitec, Inc. · 2008 · cites it directly128descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K062210	Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160	New Star Lasers, Inc.	2006	—
+1	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—
+2	K083613	Quanta System Polysurge Diode Laser Family	Quanta System Spa	2008	—
+2	K090164	Ceralas Multiwavelength 980/1470NM Diode Laser	Biolitec, Inc.	2009	—
+1	K070388	Profile Multi-Platform System	Sciton, Inc	2007	—
+1	K082225	15W Ceralas D 1470NM Diode Laser, Model D1470	Biolitec, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	9	0
2009	3	0
2010	8	0
2011	6	0
2012	4	0
2013	7	0
2014	9	0
2015	10	0
2016	10	0
2017	7	0
2018	11	0
2019	7	0
2020	14	0
2021	11	0
2022	23	0
2023	14	0
2024	25	0
2025	30	0
2026	15	0

FIG. 1 — Lineage of K062210, 2006–2026Source: 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.

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
*	—	CoolTouch Inc. Model CTEV (NS 160) Nd:YAG Laser Systems with Trac Back accessory Named without a submission number			—

What descends from it? (224)

See all 224

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

Number	Device	Applicant	Decided	Descendants
K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	202
K070388	Profile Multi-Platform System	Sciton, Inc	2007	129
K082225	15W Ceralas D 1470NM Diode Laser, Model D1470	Biolitec, Inc.	2008	128

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?

Of its descendants, K073063 (Biolitec, Inc., 2008) has gone furthest, with 202 descendants of its own.

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 CoolTouch LC160 CTEV Nd:YAG Laser System with the JouleTraker accessory is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062210 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062210: Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062210

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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