510(k) · Cleared

Cleared

Cooltouch, Model CT3S

K043046510(k) TraditionalCleared Feb 1, 200589-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 Feb 1, 2005 after an 89-day review. The FDA summary names its predicate without a number. 321 later devices descend from it.

Decided: Feb 1, 2005
Review: 89 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

321 later devices descend from it, 4 citing it directly.

This deviceK043046 Cooltouch, Model CT3SNew Star Lasers, Inc. · 2005
Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Descendant · cites it directly · 205 of its ownK053047 Fraxel SR Laser SystemReliant Technologies, Inc. · 2006
Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Descendant · 2 generations on · 195 of its ownK063038 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
Descendant · 2 generations on · 194 of its ownK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007

Showing 5 of 321 descendants. See all descendants

Descendants cleared per year

2006high 41 (2025) · low 2 (2006)2026

Most influential descendants

Showing 5 of 321 · See all

K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
K053047Fraxel SR Laser SystemReliant Technologies, Inc. · 2006 · cites it directly205descendants
K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 2 generations on202descendants
K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · 2 generations on195descendants
K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · 2 generations on194descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K043046	Cooltouch, Model CT3S	New Star Lasers, Inc.	2005	—
+1	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—
+1	K053047	Fraxel SR Laser System	Reliant Technologies, Inc.	2006	—
+2	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—
+2	K063038	Fraxel Iii SR Laser System and Accessories	Reliant Technologies, Inc.	2007	—
+2	K071051	Fraxel Iii SR Laser System and Accessories	Reliant Technologies, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2007	6	0
2008	15	0
2009	6	0
2010	11	0
2011	11	0
2012	6	0
2013	11	0
2014	12	0
2015	14	0
2016	17	0
2017	12	0
2018	17	0
2019	8	0
2020	19	0
2021	13	0
2022	28	0
2023	20	0
2024	36	0
2025	41	0
2026	16	0

FIG. 1 — Lineage of K043046, 2005–2026Source: 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 Corporation Model NS-160, CTEV Named without a submission number			—

What descends from it? (321)

See all 321

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

Number	Device	Applicant	Decided	Descendants
K060033	Profile Multi-Platform System	Sciton, Inc	2006	221
K053047	Fraxel SR Laser System	Reliant Technologies, Inc.	2006	205
K082225	15W Ceralas D 1470NM Diode Laser, Model D1470	Biolitec, Inc.	2008	128
K080697	Skin Clear SRVH Long-Pulsed ND: Yag Laser	Global USA Distribution, LLC	2008	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?

Of its descendants, K060033 (Sciton, Inc, 2006) has gone furthest, with 221 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 CT3S Nd:YAG Laser System is indicated:

a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue,

b) for use in the treatment of fine lines and wrinkles,

c) for treatment of back acne and atrophic acne scars,

d) for treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043046 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043046: Cooltouch, Model CT3S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043046

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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