510(k) · Cleared
ClearedDornier Medilas Uropulse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Medtech America, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 21, 2013 as substantially equivalent to K122159 (Dornier Medtech America, Inc., 2013) and 2 other predicates after a 38-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Mar 21, 2013
- Review
- 38 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K936109 (1994). 34 ancestors in all, the oldest K853620 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 4 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 3 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 2 generations backK061455 Dornier Medilas H 20 LaserDornier Medtech America, Inc. · 2006
- 1 generation backK122159 Dornier Medilas H30 SolvoDornier Medtech America, Inc. · 2013
- This deviceK130344 Dornier Medilas UropulseDornier Medtech America, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −7 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −5 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −4 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −3 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −2 | K061455 | Dornier Medilas H 20 Laser | Dornier Medtech America, Inc. | 2006 | — |
| −1 | K122159 | Dornier Medilas H30 Solvo | Dornier Medtech America, Inc. | 2013 | — |
| 0 (this device) | K130344 | Dornier Medilas Uropulse | Dornier Medtech America, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K122159 | Dornier Medilas H30 SolvoSummary page 1…nch has classified Surgical Powered Laser Instruments (Product Code GEX) as a Class 11device pursuant to 21 C.F.R. § 878.4810. Predicate Devices Dornier Medilas H Solvo K122159 Dornier Medilas H20 Laser K061455 Versa Pulse P20 (K1 00228) Purpose of the Special 510(k) Notice The Uropulse is a modification… | 2013 |
| * | K061455 | Dornier Medilas H 20 LaserSummary page 1…d Laser Instruments (Product Code GEX) as a Class 11device pursuant to 21 C.F.R. § 878.4810. Predicate Devices Dornier Medilas H Solvo K122159 Dornier Medilas H20 Laser K061455 Versa Pulse P20 (K1 00228) Purpose of the Special 510(k) Notice The Uropulse is a modification to the Dornier Medilas H Solvo La… | 2006 |
| * | K100228 | Versapulse Model P20 Laser SystemSummary page 1…uct Code GEX) as a Class 11device pursuant to 21 C.F.R. § 878.4810. Predicate Devices Dornier Medilas H Solvo K122159 Dornier Medilas H20 Laser K061455 Versa Pulse P20 (K1 00228) Purpose of the Special 510(k) Notice The Uropulse is a modification to the Dornier Medilas H Solvo Laser (K122159). Device Des… | 2010 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 34 ancestors has a recall of any class.
- 1 other device also cites its predicate K122159.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Uropulse is intended to be used for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Uropulse is indicated for use in medicine and surgery, in the following medical specialties:
Arthroscopy
Urology
Lithotripsy
Pulmonology
Gastroenterology
Gynecology
ENT
General Surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130344: Dornier Medilas Uropulse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130344
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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