General/multiple surgical frequency double solid-state laser system - India CDSCO Medical Device Registration

Product Information

The GreenLight XPS Laser System is intended for the surgical incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Suggested applications include: • General Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue as well as in endoscopic (Auriga XL 4007 Laser System) or open surgeries. • Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (Auriga XL 4007 Laser System); gastrointestinal tissue ablation (Auriga XL 4007 Laser System). • Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids. • Head and Neck/Otorhinolaryngology (Auriga XL 4007 Laser System): Tissue incision, excision, ablation, and vessel hemostasis. • Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type. • Ophthalmology: Post-vitrectomy endophotocoagulation of the retina. • Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures. • Spinal Surgery: Percutaneous lumbar discectomy. • Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoracoscopic or open procedures. • Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (Auriga XL 4007 Laser System) including treatment of bladder, urethral and ureteral tumors; condylomata; lesions of external genitalia; urethral and penile hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from Benign Prostatic Hyperplasia (Auriga XL 4007 Laser System). The GreenLight XPS Laser System is intended for the hospital, office, and outpatient surgery center markets