510(k) · Cleared
ClearedMultipulse TM+1470
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 Jan 30, 2015 as substantially equivalent to K120231 (Biolitec Medical Devices, Inc., 2012) and 1 other predicate after a 406-day review. Its family tree reaches back 20 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 30, 2015
- Review
- 406 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K943450 (1995). 339 ancestors in all, the oldest K771218 (1978). 3 later devices descend from it, 3 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK100726 Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM…Biolitec, Inc. · 2010
- 2 generations backK112013 Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc. · 2012
- 1 generation backK120231 Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012
- This deviceK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
- Descendant · cites it directly · 1 of its ownK253100 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
- Descendant · cites it directly · 0 of its ownK202041 Opera EvoQuanta System Spa · 2020
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 7 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 6 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 3 generations backK100726 Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM…Biolitec, Inc. · 2010
- 2 generations backK112013 Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc. · 2012
- 1 generation backK120231 Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012
- This deviceK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −7 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −6 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −3 | K100726 | Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM… | Biolitec, Inc. | 2010 | — |
| −2 | K112013 | Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser | Biolitec, Inc. | 2012 | — |
| −1 | K120231 | Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual) | Biolitec Medical Devices, Inc. | 2012 | — |
| 0 (this device) | K133891 | Multipulse TM+1470 | Asclepion Laser Technologies GmbH | 2015 | — |
| +1 | K253100 | MultiPulse TFL | Asclepion Laser Technologies GmbH | 2025 | — |
| +1 | K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026 | — |
| +1 | K202041 | Opera Evo | Quanta System Spa | 2020 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K120231 | Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Summary page 6…y 79-GEX 21 CFR 878.4810 Equivalent Devices: Evolve HPD 980/1470 Multiwavelength Diode Laser K120231 Quanta System Cyber Tm 150 Watt K102749 Device Description: The MultiPulse Tm+14… | 2012 |
| * | K102749 | Quanta Cyber TM 150WSummary page 6…Equivalent Devices: Evolve HPD 980/1470 Multiwavelength Diode Laser K120231 Quanta System Cyber Tm 150 Watt K102749 Device Description: The MultiPulse Tm+1470 laser system and its fiber optic delivery system… | 2010 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 17 of the 339 ancestors have a recall of any class.
- Of its descendants, K253100 (Asclepion Laser Technologies GmbH, 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 MultiPulse TM+1470 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 haemostasis 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…
Read the full statement (379 words)
The MultiPulse TM+1470 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 haemostasis
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 (HoLRP)
Laser Enucleation of the Prostate (HoLEP)
Laser Ablation of the Prostate (HoLAP)
Condylomas
Lesions of external genitalia
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 vlcers
Duodenal ulcers
Non Bleeding Ulcers
Pancreatitas
Hemorrhoids
Cholecystectomy
Benign and Malignant Neoplasm Angiodysplasia
Colorectal cancer
Telangiectasia
Telangiectasia of the Osler-Weber-Renu disease
Vascular Malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices
Colitis
Mallory-Weiss tear
Gastric Erosions
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and
hemostasis):
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 of the 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
Hernijorrhaphy
Tonsillectomy
Lymphadenectomy
Partial Nephrectomy
Pilonidal Cystectomy
Resection of lipoma
Debridement of Decubitus Ulcer
Hemorrhoids
~ Debridement of Statis Ulcer
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue):
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
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/K133891 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133891: Multipulse TM+1470.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133891
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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