# K131987: Multipulse Hoplus

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Oct 15, 2014 after 474 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: 6 generations back to K936109 (1994). 32 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111475: Auriga XL, Starmedtec GmbH (2011) Summary page 6.
- K002308: Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model 1210-VHP and 1500-a, Trimedyne, Inc. (2000) Summary page 6.
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 6.

## Most influential descendants
- K161257: MultiPulse HoPLUS (2017), 1 descendant of its own
- K253633: Holmium Laser Therapeutic Apparatus (HZ-40) (2026), 0 descendants of its own

## Indications for use
The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and use in medical specialties including: Urology, Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery. Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulatlon 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 (BHP), * Transurethral incision of the prostate (TUIP) * Holmiurn Laser Resection of the Prostate (HoLRP) « Holmium Laser Enucleation of the Prostate (HoLEP) » Holmiurm laser Ablation of the Prostate (HoLAP) » Condylomas * Lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy « Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calciym oxalate * dehydrate stones. *» Endoscopic fragmentation of kidney calculi * Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed. Gastroenterology Open and endoscopic gastroenterology surgery (mcis:on, excision, resection, ablation, vaporization, coagulation and haemostasis) 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 Neoplasm * Angiodysplasia * Colorectal cancer * Telangiectasias = Telangiectasias of the Osler-Weber-Renu disease » Vascular Malformation *» Gastritis « Esophagitis + Esophageal ulcers *» Varices + Colitis * Mallory-Weiss tear * Gastric Erosions Axthroscopy Arthroscopy/Orthopedic surgety (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: » Ligament and tendon Release » Contouring and sculpting of articular surfaces * Capsulectomy in the knee » Chondreoplasty in the knee « Debridement of inflamed synovial tissue » Chondromalacia Ablation * Chondromalacia and tears * Plica Removal » Meniscectomy * Loose body Debridement * Lateral retineacular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including » Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, including Forminoplasty * Percutaneous Cervical Disc Decompression/Discectomy « Percutaneous Thoracic Disc Decompression/Discectomy Pulmonary Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) Gynecclogy Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: « Endonasal / sinus Surgery » Partial turbinectomy » Polypectomy * Dacryocystorhinostomy » Frontal Sinustomy Ethmoidectomy » Maxillary antrostorny » Functional endoscopic sinus surgery Dermatology and Plastic Surgery , Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including; « Basal Cell Carcinomas » Lesions of skin and subcutaneous tissue « Skin tags * Plantar warts « Lesions of skin and subcutaneous tissue *» Port Wine Stains * Papillomas General Surgery Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: » Appendectomy « Skin incision « Excision of external lesions » Complete or partial resection of internal organs, tumors and lesions * Biopsy

Source page: https://510kreport.com/device/K131987
Methodology: https://510kreport.com/methodology