创新器械获批上市！碎石用激光治疗

Core Viewpoint - The article discusses the approval of the Nd:YAG laser treatment machine by the National Medical Products Administration, highlighting its innovative technology and potential benefits in medical applications [2][4]. Group 1: Product Approval and Technology - The Nd:YAG laser treatment machine was approved on February 27, 2026, by the National Medical Products Administration [2]. - The device is designed for use in urology and biliary systems for stone fragmentation, utilizing dual-frequency dual-pulse laser technology to enhance treatment safety and minimize damage to soft tissue [2]. Group 2: Company Background - Keying Laser, established in 2003, focuses on the research, production, and customer service of medical laser equipment, with applications across various medical fields including dermatology, surgery, ENT, dentistry, gynecology, plastic surgery, rehabilitation, and ophthalmology [4]. - The company’s products are exported to multiple regions including Europe, the Middle East, South America, and Southeast Asia [4]. Group 3: Regulatory Process - The device entered the innovative channel for review in March 2022, taking approximately four years to receive approval [4].