Manufacturer
Asclepion Laser Technologies GmbHMultiPulse HoPLUS
Asclepion Laser Technologies GmbH
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K161257
- Device name
- MultiPulse HoPLUS
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-05-04
- Decision date
- 2017-03-31
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
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 incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery. 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-SI lumbar discs, including - Foraminoplasty - Percutaneous Cervical Disc Decompression/Discectomy - Percutaneous Thoracic Disc Decompression/Discectomy Pulmonary Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue) Gynecology Open and laparoscopic gynecological surg
Intended Use
The MultiPulse HoPLUS Laser system and its fiber 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, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Device Description
The MultiPulse HoPLUS Laser system and its fiber optic delivery system is a laser Class IV, pulsed, solid state Holmium-YAG, which emits laser radiation with a wavelength of approximately 2100 nm with a pulse with between 150-1700 microseconds. The laser power up to 140 Watts is transmitted to the tissue through different optical fibers. The laser system consists of: Laser system including control panel (user interface), Foot switch, A variety of application fibers and accessories.
Summary parsed at:2026-06-01 05:58:45 UTC
Predicate devices
2Cited as predicate
5Litho 150, Cyber Ho 150
Dornier Thulio
Litho 60; Litho 100; Litho 150
Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
Holmium Laser Therapeutic Apparatus (HZ-40)
5 submissions cite K161257 as a predicate
