MultiPulse HoPLUS

Asclepion Laser Technologies GmbH

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

5

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

2

K161257 references 2 predicate/reference devices

Cited as predicate

5

5 submissions cite K161257 as a predicate