Thuvera™ Laser System - General/multiple surgical solid-state laser system

Intended purpose

Laser system intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, and lithotripsy. Urology · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] · Laser Resection of the Prostate (LRP) · Laser Enucleation of the Prostate (LEP) · Laser Ablation of the Prostate (LAP) · Transurethral Incision of the Prostate (TUIP) · Bladder neck incisions (BNI) · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors Lithotripsy and Percutaneous Urinary Lithotripsy: · Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones · Endoscopic fragmentation of renal calculi · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed