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半岛大超炮(聚焦超声皮肤治疗仪)
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医美“超声炮” 首拿“三类证”
Shen Zhen Shang Bao· 2025-11-04 06:42
Core Viewpoint - The issuance of the first Class III certificate for ultrasound medical beauty equipment in China marks a significant breakthrough for Shenzhen Peninsula Medical Group, indicating the entry of domestic ultrasound medical devices into a higher compliance era [1][2][4] Industry Summary - The Chinese medical beauty industry is projected to exceed 400 billion yuan by 2025, driven by the booming "beauty economy" and the rapid expansion of the non-surgical light medical beauty market due to its low risk and quick recovery characteristics [2] - The term "ultrasound cannon" originated in Shenzhen, with Peninsula Medical's product being the first ultrasound medical device to receive NMPA certification in China [2][3] Company Summary - Peninsula Medical's ultrasound cannon series holds approximately 80% market share in its niche, with over 100,000 units sold and coverage in more than 10,000 hospitals and medical institutions globally [3] - The "Peninsula Big Ultrasound Cannon" took nearly four years to obtain the Class III certificate, involving extensive clinical trials and regulatory compliance [3][4] - The recent regulatory changes require ultrasound beauty devices to adhere to the strictest safety standards, with Class III devices needing clinical validation before market entry, establishing a "gold standard" for the industry [3][4]
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
Zheng Quan Ri Bao Wang· 2025-11-03 12:40
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].