510(k) · Cleared
ClearedMedical Thulium Fiber Laser Systems (UroFiber 150Q)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhein Laser Technologies Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jul 21, 2026 as substantially equivalent to K253100 (Asclepion Laser Technologies GmbH, 2025) and 1 other predicate after a 55-day review. Its family tree reaches back 22 generations to 1995.
- Decided
- Jul 21, 2026
- Review
- 55 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K943450 (1995). 341 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK120231 Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012
- 2 generations backK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
- 1 generation backK253100 MultiPulse TFLAsclepion Laser Technologies GmbH · 2025
- This deviceK261738 Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd. · 2026
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 17 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 16 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 15 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 14 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 10 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 9 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 8 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 5 generations backK100726 Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM…Biolitec, Inc. · 2010
- 4 generations backK112013 Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc. · 2012
- 3 generations backK120231 Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012
- 2 generations backK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
- 1 generation backK253100 MultiPulse TFLAsclepion Laser Technologies GmbH · 2025
- This deviceK261738 Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −17 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −16 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −15 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −14 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −10 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −9 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −8 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −5 | K100726 | Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM… | Biolitec, Inc. | 2010 | — |
| −4 | K112013 | Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser | Biolitec, Inc. | 2012 | — |
| −3 | K120231 | Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual) | Biolitec Medical Devices, Inc. | 2012 | — |
| −2 | K133891 | Multipulse TM+1470 | Asclepion Laser Technologies GmbH | 2015 | — |
| −1 | K253100 | MultiPulse TFL | Asclepion Laser Technologies GmbH | 2025 | — |
| 0 (this device) | K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 18 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 26 | 0 |
| 1998 | 22 | 0 |
| 1999 | 17 | 0 |
| 2000 | 27 | 0 |
| 2001 | 29 | 0 |
| 2002 | 33 | 0 |
| 2003 | 28 | 0 |
| 2004 | 18 | 0 |
| 2005 | 11 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K253100 | MultiPulse TFLSummary page 5…Instrument) Device Class: II Review Panel: General & Plastic Surgery 3. Predicate Device 1 510(k) Number: K253100 Applicant: Asclepion Laser Technologies Gmbh Classification Name: Laser surgical inst… | 2025 |
| * | K133891 | Multipulse TM+1470Summary page 5…plastic surgery and in dermatology Trade Name: MultiPulse TFL 4. Predicate Device 2 510(k) Number: K133891 Applicant: Asclepion Laser Technologies Gmbh Classification Name: Laser surgical inst… | 2015 |
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 31 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 17 of the 341 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Medical Thulium Fiber Laser Systems (UroFiber 150Q) is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.
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/K261738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261738: Medical Thulium Fiber Laser Systems (UroFiber 150Q).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261738
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026