510(k) · Cleared
ClearedW.O.M. Laser U100PLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine AG · GEX Powered Laser Surgical Instrument
Cleared on Oct 1, 2003 as substantially equivalent to K023041 (W.O.M. World of Medicine AG, 2002) and 1 other predicate after a 93-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Oct 1, 2003
- Review
- 93 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964760 (1997). 7 ancestors in all, the oldest K901723 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK964760 Dornier Medilas Fiber Tome LaserDornier Medtech America, Inc. · 1997
- 3 generations backK981718 Dornier Medilas HDornier Surgical Products, Inc. · 1998
- 2 generations backK983963 Dornier Medila HDornier Medtech America, Inc. · 1998
- 1 generation backK984591 Dornier Medilas H/2Dornier Surgical Products, Inc. · 1999
- This deviceK032023 W.O.M. Laser U100PLUSW.O.M. World of Medicine AG · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964760 | Dornier Medilas Fiber Tome Laser | Dornier Medtech America, Inc. | 1997 | — |
| −3 | K981718 | Dornier Medilas H | Dornier Surgical Products, Inc. | 1998 | — |
| −2 | K983963 | Dornier Medila H | Dornier Medtech America, Inc. | 1998 | — |
| −1 | K984591 | Dornier Medilas H/2 | Dornier Surgical Products, Inc. | 1999 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K023041 | W.O.M. Laser U100Summary page 3…\ -7 5100() SUMMARY Page -3- l - 3 - The differences of the W.O.M. Laser U100plu.s to the predicate device W.O.M. Laser UlOO (K023041) are minor and raise no new questions of safety and effectiveness. Moreover the differences between both devices result in… | 2002 |
| * | K984591 | Dornier Medilas H/2Summary page 2…ices are indicated for use to f i x p e n t urinary and biliary stones in the contact mode during closed surgical procedures. However, the Domier Medilas W2 (K98459 1) is also indicated for use in cutting, vaporization. ablation and coagulation of soft tissue. The W.O.M. Laser UlOOp… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 UlOOpZus is indicated for use in the contact mode to fragment urinary stones (kidney, ureter and bladder) and biliary stones in closed surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032023: W.O.M. Laser U100PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032023
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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