# K161257: MultiPulse HoPLUS

- Pathway: 510(k) (Special)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Mar 31, 2017 after 331 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: 7 generations back to K936109 (1994). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131987: Multipulse Hoplus, Asclepion Laser Technologies GmbH (2014) Summary page 6.
- K140388: Lumenis Pulse 120H, Lumenis, Ltd. (2014) Summary page 6.

## Most influential descendants
- 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 in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery. Typical Applications: 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 (BHP) * Transurethral incision of the prostate (TUIP) * Holmium Laser Resection of the Prostate (HoLRP) * Holmium Laser Enucleation of the Prostate (HoLEP) * Holmium 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 calcium 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 (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 * Telangiectasias * Telangiectasias of the Osler-Weber-Renu 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) 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-S1 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) Gynecology 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 antrostomy * 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/K161257
Methodology: https://510kreport.com/methodology