510(k) · Cleared
ClearedMultiPulse TFL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asclepion Laser Technologies GmbH · GEX Powered Laser Surgical Instrument
Cleared on Oct 23, 2025 as substantially equivalent to K133891 (Asclepion Laser Technologies GmbH, 2015) after a 29-day review. Its family tree reaches back 21 generations to 1995. 1 later device descends from it.
- Decided
- Oct 23, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K943450 (1995). 340 ancestors in all, the oldest K771218 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK112013 Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc. · 2012
- 2 generations backK120231 Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012
- 1 generation backK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
- This deviceK253100 MultiPulse TFLAsclepion Laser Technologies GmbH · 2025
- Descendant · cites it directly · 0 of its ownK261738 Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 8 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 7 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 4 generations backK100726 Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM…Biolitec, Inc. · 2010
- 3 generations backK112013 Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc. · 2012
- 2 generations backK120231 Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012
- 1 generation backK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
- This deviceK253100 MultiPulse TFLAsclepion Laser Technologies GmbH · 2025
Most influential descendants
Showing 1 of 1 · See all- K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −8 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −7 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −4 | K100726 | Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM… | Biolitec, Inc. | 2010 | — |
| −3 | K112013 | Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser | Biolitec, Inc. | 2012 | — |
| −2 | K120231 | Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual) | Biolitec Medical Devices, Inc. | 2012 | — |
| −1 | K133891 | Multipulse TM+1470 | Asclepion Laser Technologies GmbH | 2015 | — |
| 0 (this device) | K253100 | MultiPulse TFL | Asclepion Laser Technologies GmbH | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (1)
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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | 2026 | 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?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 17 of the 340 ancestors have a recall of any class.
- Of its descendants, K261738 (Rhein Laser Technologies Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K133891.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
MultiPulse TFL Laser system and its fibre optic delivery system are 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. Urology Open and endoscopic surgery…
Read the full statement (433 words)
MultiPulse TFL Laser system and its fibre optic delivery system are 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.
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Urethral Strictures
Bladder Neck Incisions (BNI)
Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BPH)
Transurethral incision of the prostate (TUIP)
Laser Resection of the Prostate Laser Enucleation of the Prostate
Laser Ablation of the Prostate
Condyloma
Lesions of external genitalia
Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
Endoscopic fragmentation of renal calculi
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitis, Hemorrhoids, Cholecystectomy, Benign and Malignant Neoplasma, Angiodysplasia, Colorectal cancer, Telangiectasia, Telangiectasia of the Osler-WeberRenu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions.
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) including: Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy, Foraminoplasty, Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasive spinal surgery.
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue: Intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septum by incision, excision, ablation and/or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix.
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: Endonasal/sinus Surgery, Partial turbinectomy, Polypectomy, Dacryocystorhinostomy, Frontal Sinusotomy, Ethmoidectomy, Maxillary antrostomy, Functional endoscopic sinus surgery, Lesions or tumors (oral, nasal, glossal, pharyngeal and laryngeal), Tonsillectomy, Adenoidectomy.
General surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy, Lysis of adhesion, Appendectomy, Biopsy, Skin incision, Tissue dissection, Excision of external tumors and lesions, Complete or partial resection of internal organs, tumors and lesions, Mastectomy, Hepatectomy, Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Tonsillectomy, Lymphadenectomy, Partial Nephrectomy, Pilonidal Cystectomy, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer.
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/K253100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253100: MultiPulse TFL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253100
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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