510(k) · Cleared

Cleared

Lightsheer Pulsed Diode Array Laser System (Family of Products)

K001746510(k) TraditionalCleared Jul 19, 200041-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

Coherent Star · GEX Powered Laser Surgical Instrument

Cleared on Jul 19, 2000 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 714 later devices descend from it.

Decided: Jul 19, 2000
Review: 41 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

714 later devices descend from it, 9 citing it directly.

This deviceK001746 Lightsheer Pulsed Diode Array Laser System (Family of Products)Coherent Star · 2000
Descendant · cites it directly · 363 of its ownK030805 Mythos 500Msq (M2), Ltd. · 2003
Descendant · 2 generations on · 301 of its ownK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
Descendant · 3 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
Descendant · cites it directly · 297 of its ownK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008

Showing 5 of 714 descendants. See all descendants

Descendants cleared per year

2001high 94 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 714 · See all

K030805Mythos 500Msq (M2), Ltd. · 2003 · cites it directly363descendants
K041959Polaris DS/CometSyneron Medical, Ltd. · 2004 · 2 generations on301descendants
K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 3 generations on299descendants
K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006 · cites it directly297descendants
K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001746	Lightsheer Pulsed Diode Array Laser System (Family of Products)	Coherent Star	2000	—
+1	K030805	Mythos 500	Msq (M2), Ltd.	2003	—
+2	K041959	Polaris DS/Comet	Syneron Medical, Ltd.	2004	—
+3	K053540	Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…	Intermedic Arfran, SA	2006	—
+1	K060448	Lumenis One Family of Systems; Lumenis One.	Lumenis, Ltd.	2006	—
+2	K072564	Alma Lasers Harmony XL Multi-Application Platform	Alma Lasers, Ltd.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	2	0
2004	1	0
2005	2	0
2006	3	0
2007	4	0
2008	13	0
2009	12	0
2010	14	0
2011	10	0
2012	16	0
2013	21	0
2014	31	0
2015	28	0
2016	36	0
2017	32	0
2018	36	0
2019	25	0
2020	37	0
2021	45	0
2022	62	0
2023	62	0
2024	76	0
2025	94	0
2026	51	0

FIG. 1 — Lineage of K001746, 2000–2026Source: 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? (714)

See all 714

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

Number	Device	Applicant	Decided	Descendants
K030805	Mythos 500	Msq (M2), Ltd.	2003	363
K060448	Lumenis One Family of Systems; Lumenis One.	Lumenis, Ltd.	2006	297
K011747	Palomar LC 100 Diode Laser	Palomar Medical Technologies, Inc.	2001	174
K032846	Spectra Pulsed Diode Laser, Model DR-1	Spectragenics, Inc.	2003	173
K052848	Spectra Hair Removal Laser	Spectragenics, Inc.	2005	172
K053527	Spectra Hair Removal Laser	Spectragenics, Inc.	2008	169
K083848	Alma Lasers Soprano XL Multi-Application Platform	Alma Lasers, Ltd.	2009	125
K090762	LEDA	Quantel Derma GmbH	2009	46
K123682	Inmode Hair Removal (HR) Device	Inmode MD, Ltd.	2013	1

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, K030805 (Msq (M2), Ltd., 2003) has gone furthest, with 363 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/K001746 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001746: Lightsheer Pulsed Diode Array Laser System (Family of Products).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001746

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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