Core Insights - The Chinese medical aesthetics device industry is undergoing a historic transformation from "technology following" to "innovation leading," driven by the dual waves of beauty economy and technological skincare. By 2025, the market size is expected to reach 324.7 billion yuan, showcasing significant consumer potential and innovation momentum [1] Market Dynamics - The medical aesthetics industry is experiencing a "trust upgrade," with regulatory bodies increasing oversight to emphasize medical safety and product quality. This shift is moving the industry from "scale expansion" to "value creation," making trust a core demand. The high-end medical device market in China is growing at an annual rate of over 20%, with advanced technologies like medical robots and AI medical devices witnessing explosive growth [2] - The NMPA Class III medical device certification has become the "gold standard" for medical aesthetic equipment, requiring rigorous clinical validation and expert review before market entry. The certification of the "Half Island Counterclockwise" device marks a significant achievement in the domestic golden microneedle sector, reflecting reforms in the medical device review system and national support for high-end medical device innovation [2] Sales Performance - The "Half Island Counterclockwise" has achieved remarkable market performance, consistently ranking at the top in consumer satisfaction and transaction volume on platforms like Meituan. The product has garnered nearly 1.7 billion views on social media platforms, indicating strong user recognition and repurchase rates [5] - Clinical trials led by authoritative hospitals show a satisfaction rate exceeding 90% among participants, reinforcing consumer confidence in the product [5] Technological Innovation - The "Half Island Counterclockwise" introduces a groundbreaking "mixed bipolar and unipolar multi-mode output technology," addressing the uneven energy distribution issues of traditional microneedles. This innovation allows for comprehensive treatment in a single operation, enhancing both coverage and precision [6] - The device supports operations on special areas like eyelids and necks, achieving a breakthrough where "one operation equals five skin rejuvenation sessions" [6] Research and Development - The company invests 25%-27% of its revenue annually into R&D, with a team of nearly 400 researchers, constituting about 30% of its workforce. It has filed over 500 patents in the RF field, establishing a solid academic foundation [7] Global Expansion - The year 2025 marks a pivotal point for the company's global strategy, with efforts to translate insights from the U.S. medical aesthetics market into engineering solutions. The company emphasizes a philosophy of "Beauty With No Boundary," focusing on balancing comfort, efficiency, and experience [9][10] - A systematic market research initiative has been launched to gather firsthand insights from clinics and consumers, leading to a comprehensive understanding of the U.S. medical aesthetics landscape [10] Industry Outlook - The Chinese medical aesthetics device sector is entering a golden development period, supported by national policies that accelerate innovation in high-end medical devices. The company has positioned itself among the top six global energy source medical device enterprises, with products sold in over 70 countries [15] - Continuous innovation and technological upgrades have allowed the "Half Island Counterclockwise" to define the ultimate form of golden microneedles, reflecting both market choice and technological strength [15][16]

从医疗器械分类管理的逻辑来看，按照风险程度，医疗器械被分为一、二、三类，风险递增，监管也递 增严格。三类医疗器械被视为"最高管理规格"，包括植入式心脏起搏器、人工关节等高风险产品，其临 床下证要求极其严格，被业内称为"医疗器械界的珠峰"。 而三类证的下证流程通常需要经历产品研发、临床前研究、临床试验、技术审评、行政审批等多个环 节，整个周期往往长达数年。其中，临床试验是最大的门槛——需要在多家医疗机构进行大样本量的临 床验证，收集足够的安全性和有效性数据，且必须经过伦理委员会审查和严格的监管审核。 半岛医疗向观察者网透露表示，为了完成"半岛逆时针"的临床验证，由中国人民解放军总医院第七医学 中心牵头，多中心核心专家团队参与的"逆时针"安全性和有效性研究发现，"逆时针"癫痕改善效果显 著，受试者满意度高达90%以上。在医美市场信息不对称严重、虚假宣传泛滥的当下，这种官方背书显 得尤为重要。 事实上，三类证下发的迫切性，源于长期以来医美器械市场的监管真空。观察者网此前曾多次报道医美 行业乱象：无资质机构违规经营、低价引流后诱导消费、使用走私或假冒器械、夸大宣传治疗效果等问 题层出不穷。 10月29日，一张医疗器械 ...