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Laser Cutting Machine Used in Surgery - Vietnam Registration 2403032ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Laser Cutting Machine Used in Surgery in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403032ĐKLH/BYT-HTTB and manufactured by Boston Scientific Corporation. The authorized representative in Vietnam is CÔNG TY TNHH BOSTON SCIENTIFIC VIỆT NAM.

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2403032ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403032ĐKLH/BYT-HTTB
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Device Details

Laser Cutting Machine Used in Surgery
VN: Máy cắt đốt Laser dùng trong phẫu thuật
Risk Class TTBYT Loại C

Registration Details

2403032ĐKLH/BYT-HTTB

000.00.04.G18-221227-0026

GreenLight XPS™ Laser System

0010-0210S-G0; 0010-0210S-GD0; 0010-0210S-GH0; 0010-0210S-GR0; 0010-0210S-GZ0

Company Information

UNITED STATES

Boston Scientific

Technical Details

The GreenLight XPS Laser Cutting System used in surgery is designed to perform surgical incision, dissection, vaporization, ablation, hemostasis, and coagulation of soft tissue. It includes all types of soft tissue, such as skin, subcutaneous tissue, vascular tissue, smooth muscle, chondrocyte, mucosa, blood vessels, lymph nodes, organs, and glands. The recommended applications include: • General Surgery: Vaporization, hemostasis, incision, ablation, dissection, and resection of soft tissue, both endoscopic and open surgery. • Gastroenterology: Excision and hemostasis of the gastrointestinal tract; metaplasia of the esophagus, including squamous cell carcinoma and adenocarcinoma; hemostasis of the gastrointestinal tract (including esophageal varices, esophagitis, Mallory-Weiss tear, peptic ulcer, antral gastritis, vascular dysplasia, peptic ulcer, non-bleeding ulcer, and esophageal erosion); resection of the gastrointestinal tract (benign and malignant tumors, vascular dysplasia, polyps, peptic ulcer, inflammatory bowel disease, hemorrhoids). • Obstetrics and Gynecology: Vaporization, incision, or hemostasis of soft tissue related to the treatment of endometriosis; metaplasia of the cervix, vagina, and vulva; genital warts; uterine septum; adhesions in the uterus; submucosal uterine fibroids. • Head and Neck / ENT: Dissection, dissection, resection, and hemostasis of blood vessels. • Neurosurgery: Excision, stimulation, hemostasis, and vaporization of complex, rigid neurofibromas. • Ophthalmology: Coagulation of the retinal pigment epithelium after cataract surgery. • Plastic Surgery: Vaporization, coagulation, incision, resection, and dissection of soft tissue in endoscopic and open surgical procedures. • Spinal Surgery: Excision of the lumbar region through the skin. • Thoracic Surgery: Vaporization, coagulation, incision, resection, and dissection of soft tissue, including lung tissue, in endoscopic and open surgical procedures of the thorax. • Urology: Excision, coagulation, or vaporization of urological soft tissue. Minimally invasive endoscopic open urological surgery (excision, vaporization, incision, and hemostasis of soft tissue) includes the treatment of bladder, urethral, and renal tumors; the cervix; damage to the external genitalia; blood clots in the urethra and penis; urethral obstruction; and vaporization of the prostate tissue in men with benign prostatic hyperplasia (BPH). The GreenLight XPS Laser Cutting System ™ is designed for use in hospitals, clinics, and ambulatory surgery centers.

Dates and Status

Nov 02, 2024