510(k) · Cleared

Cleared

W.O.M. Laser U100

K023041510(k) TraditionalCleared Dec 11, 200290-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

W.O.M. World of Medicine AG · GEX Powered Laser Surgical Instrument

Cleared on Dec 11, 2002 as substantially equivalent to K011175 (W.O.M. World of Medicine GmbH, 2001) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Dec 11, 2002
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K901723 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK901723 MDL-2000 LasertripterCandela Laser Corp. · 1990
This deviceK023041 W.O.M. Laser U100W.O.M. World of Medicine AG · 2002
Descendant · cites it directly · 0 of its ownK032023 W.O.M. Laser U100PLUSW.O.M. World of Medicine AG · 2003

Most influential descendants

Showing 1 of 1 · See all

K032023W.O.M. Laser U100PLUSW.O.M. World of Medicine AG · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901723	MDL-2000 Lasertripter	Candela Laser Corp.	1990	—
0 (this device)	K023041	W.O.M. Laser U100	W.O.M. World of Medicine AG	2002	—
+1	K032023	W.O.M. Laser U100PLUS	W.O.M. World of Medicine AG	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K023041, 1990–2003Source: 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
*	K011175	W.O.M. Laser U100	W.O.M. World of Medicine GmbH	2001	—
*	K901723	MDL-2000 Lasertripter Summary page 1 …Predicate Devices: 0 W.O.M. Laser UlOO (KO1 1175) manufactured by W.O.M. WORLD OF MEDICINE AG 0 Candela MDL-2000 Laser LithoTripter (K901723) manufactured by Candela Laser Corporation. V. Intended Use and Indication for Use: 0 The W.O.M. Lase…	Candela Laser Corp.	1990	—

Also cleared against K011175: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K032023	W.O.M. Laser U100PLUS	W.O.M. World of Medicine AG	2003	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K032023 (W.O.M. World of Medicine AG, 2003) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K011175.

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 W.O.M. Laser UlOO is indicated for use in the contact mode to fiagment urinary stones (kidney, ureter, bladder) and biliary stones in closed surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023041 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023041: W.O.M. Laser U100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023041

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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