510(k) · Cleared

Cleared

6 Watt Holmium Laser System

K952489510(k) TraditionalCleared Jan 22, 1996237-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 Jan 22, 1996 after a 237-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 727 later devices descend from it.

Decided: Jan 22, 1996
Review: 237 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

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

This deviceK952489 6 Watt Holmium Laser SystemNew Star Lasers, Inc. · 1996
Descendant · cites it directly · 726 of its ownK962791 New Star Model 130 6-Watt ND: Yag Laser SystemNew Star Lasers, Inc. · 1997
Descendant · 2 generations on · 668 of its ownK014035 Cooltouch and Cooltouch-II ND:Yag Laser SystemsCooltouch Corp. · 2002
Descendant · 3 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
Descendant · 2 generations on · 575 of its ownK022817 Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag…Icn Pharmaceuticals, Inc. · 2002
Descendant · 3 generations on · 520 of its ownK022466 Profile 1320 Laser SystemSciton, Inc · 2002

Showing 5 of 727 descendants. See all descendants

Descendants cleared per year

1997high 84 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 727 · See all

K962791New Star Model 130 6-Watt ND: Yag Laser SystemNew Star Lasers, Inc. · 1997 · cites it directly726descendants
K014035Cooltouch and Cooltouch-II ND:Yag Laser SystemsCooltouch Corp. · 2002 · 2 generations on668descendants
K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 3 generations on665descendants
K022817Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model…Icn Pharmaceuticals, Inc. · 2002 · 2 generations on575descendants
K022466Profile 1320 Laser SystemSciton, Inc · 2002 · 3 generations on520descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K952489	6 Watt Holmium Laser System	New Star Lasers, Inc.	1996	—
+1	K962791	New Star Model 130 6-Watt ND: Yag Laser System	New Star Lasers, Inc.	1997	—
+2	K014035	Cooltouch and Cooltouch-II ND:Yag Laser Systems	Cooltouch Corp.	2002	—
+3	K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…	Altus Medical, Inc.	2002	—
+2	K022817	Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser…	Icn Pharmaceuticals, Inc.	2002	—
+3	K022466	Profile 1320 Laser System	Sciton, Inc	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	4	0
2003	7	0
2004	7	0
2005	5	0
2006	5	0
2007	16	0
2008	24	0
2009	15	0
2010	19	0
2011	24	0
2012	21	0
2013	26	0
2014	30	0
2015	27	0
2016	37	0
2017	33	0
2018	31	0
2019	23	0
2020	42	0
2021	32	0
2022	54	0
2023	42	0
2024	71	0
2025	84	0
2026	47	0

FIG. 1 — Lineage of K952489, 1996–2026Source: 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? (727)

See all 727

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

Number	Device	Applicant	Decided	Descendants
K962791	New Star Model 130 6-Watt ND: Yag Laser System	New Star Lasers, Inc.	1997	726

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, K962791 (New Star Lasers, Inc., 1997) has gone furthest, with 726 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/K952489 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952489: 6 Watt Holmium 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/K952489

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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