510(k) · Cleared

Cleared

ND: Yag Accessory for Photoderm System

K980537510(k) TraditionalCleared Apr 15, 199863-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

Esc Medical Systems, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Apr 15, 1998 after a 63-day review. The FDA summary names its predicate without a number. 1,242 later devices descend from it.

Decided: Apr 15, 1998
Review: 63 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

1,242 later devices descend from it, 4 citing it directly.

This deviceK980537 ND: Yag Accessory for Photoderm SystemEsc Medical Systems, Ltd. · 1998
Descendant · cites it directly · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
Descendant · 2 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
Descendant · 2 generations on · 756 of its ownK030342 Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · Recalled
Descendant · 2 generations on · 756 of its ownK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
Descendant · cites it directly · 755 of its ownK991234 The Acme Medical Aesthetic ND:Yag LaserAcme Medical, Inc. · 1999

Showing 5 of 1,242 descendants. See all descendants

Descendants cleared per year

1999high 136 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 1,242 · See all

K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · cites it directly1,046descendants
K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 2 generations on856descendants
K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · 2 generations on756descendants
K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd. · 2003 · 2 generations on756descendants
K991234The Acme Medical Aesthetic ND:Yag LaserAcme Medical, Inc. · 1999 · cites it directly755descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K980537	ND: Yag Accessory for Photoderm System	Esc Medical Systems, Ltd.	1998	—
+1	K020839	Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL	Lumenis, Inc.	2002	—
+2	K030527	Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems	Lumenis	2003	—
+2	K030342	Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems	Lumenis, Ltd.	2003	1
+2	K024093	Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl…	Lumenis, Ltd.	2003	—
+1	K991234	The Acme Medical Aesthetic ND:Yag Laser	Acme Medical, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2002	6	0
2003	16	0
2004	15	0
2005	24	0
2006	24	0
2007	28	0
2008	45	0
2009	34	0
2010	34	0
2011	36	0
2012	30	0
2013	47	0
2014	48	0
2015	46	0
2016	60	0
2017	62	0
2018	53	0
2019	46	0
2020	57	0
2021	54	0
2022	86	0
2023	76	0
2024	98	0
2025	136	0
2026	79	0

FIG. 1 — Lineage of K980537, 1998–2026Source: 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
*	—	Sharplan 3100 Nd:YAG Laser System Named without a submission number			—
*	—	Laserscope Orion Laser System Named without a submission number			—

What descends from it? (1,242)

See all 1,242

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

Number	Device	Applicant	Decided	Descendants
K020839	Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL	Lumenis, Inc.	2002	1,046
K991234	The Acme Medical Aesthetic ND:Yag Laser	Acme Medical, Inc.	1999	755
K014040	Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…	Altus Medical, Inc.	2002	739
K030186	Polris LV	Syneron Medical, Ltd.	2003	680

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, K020839 (Lumenis, Inc., 2002) has gone furthest, with 1,046 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 PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980537 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980537: ND: Yag Accessory for Photoderm System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980537

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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