13/12/2023
WEGO Green Laser Surgical System Obtains Class III Medical Device Registration Certificate
The Nd:YAG frequency-doubled laser treatment equipment (referred to as the "green laser device") independently developed by WEGO Laser Medical Equipment Co., Ltd. (hereinafter referred to as the "Company") obtained the Class III medical device registration certificate issued by the National Medical Products Administration on December 4th (registration number: Guoxiezhun20233011826), marking WEGO's leading position in the domestic field of prostate enlargement medical products.
Benign prostatic hyperplasia (BPH) is a common urinary obstruction disease in middle-aged and elderly men. Its incidence increases with age, with over 50% of men over 60 years old suffering from BPH, reaching as high as 90% by the age of 80. With the continued aging of the population, the number of BPH patients is increasing year by year.
In the past, TURP (Transurethral Resection of the Prostate) was considered the gold standard for BPH treatment. However, clinical findings have revealed that it is not suitable for patients with anesthesia intolerance, advanced age, heart stents, pacemakers, and high-risk patients, with high intraoperative bleeding and high risk for patients taking anticoagulants. Additionally, there are numerous postoperative complications and a long recovery period. In recent years, the rise of laser technology has effectively addressed the contraindications of TURP.
The green laser device can efficiently vaporize gland tissues of any volume and shape, with a high power cutting rate, no bleeding during surgery, clear visibility, significantly shortened operation time, greatly improved safety and effectiveness of surgery, and is suitable for elderly patients or high-risk patients with concomitant cardiovascular and cerebrovascular diseases (including those with heart pacemakers, coronary artery stents), chronic pulmonary diseases, diabetes, thrombocytopenia, and the need for anticoagulant therapy. It has fewer postoperative complications, rapid recovery, and can be performed as a day surgery.
https://wegomedical.co.ke/wego-green-laser-surgical-system-obtains-class-iii-medical-device-registration-certificate/