Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Empower H65 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, Gynaecology, ENT and General Surgery. Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) 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) • 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 haemostasis) including: • Appendectomy • Polyps • Biopsy • Gall Bladder calculi • Biliary/Bile duct calculi • Ulcers • Gastric ulcers • Duodenal ulcers • Non Bleeding Ulcers • Pancreatitis • Haemorrhoids • Cholecystectomy • Benign and Malignant Neoplasm • Angiodysplasia • Colorectal cancer • Telangiectasias • Telangiectasias of the Osler-Weber-Rendu disease • Vascular Malformation • Gastritis • Esophagitis • Esophageal ulcers • Varices • Colitis • Mallory-Weiss tear • Gastric Erosions Arthroscopy Arthroscopy/Orthopaedic 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 • Chondreplasty in the Knee • Debridement of inflamed synovial tissue • Chondromalacia Ablation • Chondromalacia and tears • Plica Removal • Meniscectomy • Loose Body Debridement • Lateral retinacular 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 Foraminoplasty • Percutaneous Cervical Disc Decompression/Discectomy • Percutaneous Thoracic Disc Decompression/Discectomy Gynaecology Open and laparoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue. ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization,
The Empower H65 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, Gynaecology, ENT and General Surgery.
Summary parsed at:2026-06-01 05:57:10 UTC
