Device Dossier
Surgical Ho:YAG laser system
Device Dossier for Surgical Ho:YAG laser system (General/multiple surgical solid-state laser system, Class IIb, sponsor Coloplast). ARTG record, intended…
- GMDN category: General/multiple surgical solid-state laser system
Intended purpose
The Coloplast TFL Drive laser device and its accessories are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and lithotripsy of stones in use in medical specialties including: Urology, Thoracic and Pulmonary, ENT, Neurosurgery, Gastroenterology, Gynecology and General Surgery.