510(k) · Cleared

Cleared

Cooltouch Varia ND:Yag Laser System; Cooltouch Varia-II ND:Yag Laser System

K010316510(k) TraditionalCleared May 1, 200188-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

Cooltouch Corp. · GEX Powered Laser Surgical Instrument

Cleared on May 1, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 520 later devices descend from it.

Decided: May 1, 2001
Review: 88 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

520 later devices descend from it, 1 citing it directly.

This deviceK010316 Cooltouch Varia ND:Yag Laser System; Cooltouch Varia-II ND:Yag Laser…Cooltouch Corp. · 2001
Descendant · cites it directly · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Descendant · 3 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008

Showing 5 of 520 descendants. See all descendants

Descendants cleared per year

2004high 63 (2024) · low 1 (2005)2026

Most influential descendants

Showing 5 of 520 · See all

K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · cites it directly519descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 3 generations on266descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010316	Cooltouch Varia ND:Yag Laser System; Cooltouch Varia-II ND:Yag Laser System	Cooltouch Corp.	2001	—
+1	K033251	The Friendlylight ND: Yag Lasers	Innotech USA, Inc.	2004	—
+2	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—
+3	K072564	Alma Lasers Harmony XL Multi-Application Platform	Alma Lasers, Ltd.	2008	—
+3	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—
+4	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—

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	15	0
2009	6	0
2010	14	0
2011	14	0
2012	12	0
2013	14	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	42	0
2023	32	0
2024	63	0
2025	61	0
2026	38	0

FIG. 1 — Lineage of K010316, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (520)

See all 520

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

Number	Device	Applicant	Decided	Descendants
K033251	The Friendlylight ND: Yag Lasers	Innotech USA, Inc.	2004	519

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, K033251 (Innotech USA, Inc., 2004) has gone furthest, with 519 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	—

https://510kreport.com/device/K010316 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010316: Cooltouch Varia ND:Yag Laser System; Cooltouch Varia-II ND:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010316

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026