国内首张超声医美器械三类证下发 半岛医疗开启无创抗衰新阶段

Core Viewpoint - Shenzhen Peninsula Medical Group Co., Ltd. has announced that its third-generation ultrasound device, "Peninsula Ultra Cannon," has received the Class III medical device registration certificate, making it the first ultrasound aesthetic device in China to obtain such certification [1][2]. Group 1: Product Details - The "Peninsula Ultra Cannon" utilizes focused ultrasound thermal effects to treat skin laxity in the lower face, chin, and neck areas [1]. - The Class III medical device registration indicates that the product has undergone rigorous clinical trials to validate its safety and effectiveness [1][2]. Group 2: Clinical Research and Validation - The registration project for the "Peninsula Ultra Cannon" began in January 2021 and included extensive clinical trials, with approval granted in September 2023 [2]. - Clinical studies conducted in collaboration with top-tier hospitals showed a satisfaction rate exceeding 90% among participants regarding the device's effectiveness in improving skin laxity [2]. Group 3: Industry Impact - The approval of the "Peninsula Ultra Cannon" is seen as a significant advancement for the domestic medical aesthetics industry, providing a new technology that promotes standardized development in the ultrasound aesthetic market [2]. - Industry experts emphasize the need for more investment in research and innovation from upstream medical aesthetic companies to develop safer and more effective products [2].