510(k) · Cleared

Cleared

Cooltouch ND: Yag Laser System

K030453510(k) TraditionalCleared May 12, 200390-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 May 12, 2003 as substantially equivalent to K014128 (Candela Corp., 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 2000. 524 later devices descend from it.

Decided: May 12, 2003
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K002421 (2000). 5 ancestors in all. 524 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK002421 Candela Mid IR Diode Laser SystemCandela Corp. · 2000
2 generations backK013825 Candela Smoothbeam Laser SystemCandela Corp. · 2002 · Recalled
1 generation backK022884 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
This deviceK030453 Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc. · 2003
Descendant · cites it directly · 518 of its ownK032459 Profile 1320 Laser SystemSciton, Inc · 2004
Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008

Showing 5 of 524 descendants. See all descendants

Descendants cleared per year

2004high 63 (2024) · low 1 (2005)2026

Most influential descendants

Showing 5 of 524 · See all

K032459Profile 1320 Laser SystemSciton, Inc · 2004 · cites it directly518descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K002421	Candela Mid IR Diode Laser System	Candela Corp.	2000	—
−2	K013825	Candela Smoothbeam Laser System	Candela Corp.	2002	1
−1	K022884	Candela Smoothbeam Laser System	Candela Corp.	2003	1
0 (this device)	K030453	Cooltouch ND: Yag Laser System	New Star Lasers, Inc.	2003	—
+1	K032459	Profile 1320 Laser System	Sciton, Inc	2004	—
+1	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—
+2	K072564	Alma Lasers Harmony XL Multi-Application Platform	Alma Lasers, Ltd.	2008	—
+2	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—
+3	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	1	0
2006	3	0
2007	8	0
2008	17	0
2009	6	0
2010	14	0
2011	14	0
2012	11	0
2013	15	0
2014	20	0
2015	20	0
2016	32	0
2017	24	0
2018	25	0
2019	14	0
2020	33	0
2021	27	0
2022	43	0
2023	33	0
2024	63	0
2025	61	0
2026	38	0

FIG. 1 — Lineage of K030453, 2000–2026Source: 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? (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
*	K014128	Candela Smoothbeam Laser System	Candela Corp.	2002	—
*	K022884	Candela Smoothbeam Laser System	Candela Corp.	2003	1

Also cleared against K014128: 3 other devices →

What descends from it? (524)

See all 524

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

Number	Device	Applicant	Decided	Descendants
K032459	Profile 1320 Laser System	Sciton, Inc	2004	518
K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	517
K073111	Portrait PSR, Model 745915	Rhytec Incorporated	2008	4

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 3 years and passes through 2 companies; a new generation was cleared every 11 months on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K032459 (Sciton, Inc, 2004) has gone furthest, with 518 descendants of its own.
3 other devices also cite its predicate K014128.

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 CoolTouchB ND:YAG Laser System is indicated for:

1. treatment of back acne

2. treatment of atrophic acne scars

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030453 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030453: Cooltouch ND: Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030453

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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