# K133891: Multipulse TM+1470

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Jan 30, 2015 after 406 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K943450 (1995). 339 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 343 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120231: Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual), Biolitec Medical Devices, Inc. (2012) Summary page 6.
- K102749: Quanta Cyber TM 150W, Quanta System Spa (2010) Summary page 6.

## Most influential descendants
- K253100: MultiPulse TFL (2025), 1 descendant of its own
- K261738: Medical Thulium Fiber Laser Systems (UroFiber 150Q) (2026), 0 descendants of its own
- K202041: Opera Evo (2020), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K133891
Methodology: https://510kreport.com/methodology