国产射频微针（俗称"黄金微针"）的首张"械三证"来了。 10月29日，半岛医疗宣布旗下的射频皮肤治疗仪（下称"半岛逆时针"）正式获批第三类医疗器械注册 证。 这是首个获得"械三证"的国产黄金微针设备。 据半岛医疗介绍，"半岛逆时针"集成了单极、双极、单双极联合三模式于一体的射频微针，在搭配"动 态分层技术"后既兼顾了皮肤不同部位的治疗，也保证了能量能够集中输出，无需像传统项目那样，为 了不同需求多次进行治疗，既节省了时间成本，又大幅降低了治疗过程中的不适感，主要用于治疗痤疮 等。 在此之前，半岛逆时针已获得FDA 510（k）注册证，加上此次获批国内的"械三证"，其已成为目前国 产首个NMPA、FDA双认证的三类射频微针。 随着此次半岛逆时针获批后，国产射频产品有望迎来扩容。 "械三证"的获批契合有关部门对黄金微针等射频类产品的监管方向。 信风注意到，今年3月华东医药（000963.SZ）的光学射频治疗仪V30"械三证"申请已获药监局受理。 2024年7月，药监局发布的《关于进一步明确射频治疗仪类产品有关要求的公告》，要求自 2026年4月1 日起，射频治疗仪、射频皮肤治疗仪类产品需要从二类医疗器械证升级为三 ...

Core Insights - Viora Ltd., a wholly-owned subsidiary of Huadong Medicine, received acceptance for its V30 optical radiofrequency therapy device registration application from the National Medical Products Administration (NMPA) [1] - The V30 device integrates multiple energy sources including RF, IPL, and Nd:YAG laser, providing versatile treatment options for various skin issues [1] - The medical aesthetic energy device market is experiencing rapid growth, with significant consumer interest in energy-based treatments [4][3] Company Developments - Viora was acquired by Huadong Medicine's UK subsidiary Sinclair in February 2022, marking a strategic expansion into the medical aesthetics sector [1] - The V30 device has already received FDA and EU CE certifications, indicating its compliance with international standards [3] - The acceptance of the V30 registration application will enhance Huadong Medicine's product portfolio in the domestic medical aesthetics market [10] Market Overview - The Chinese medical aesthetics market for optical devices reached a scale of 35.674 billion yuan in 2022, with an estimated market size of 13.503 billion yuan in 2023 [5] - The market for medical aesthetic energy devices is projected to grow to 19.289 billion yuan by 2028 [6] - There is a notable increase in high-end consumer willingness to spend on medical aesthetics, with 26% of surveyed individuals indicating annual spending over 50,000 yuan in 2023 [7] Competitive Landscape - Despite the growth in the domestic market, high-end optical device manufacturers in China are still in the development phase, with foreign companies dominating the mid-to-high-end market [8] - There is a pressing need for more diverse and high-quality compliant medical aesthetic energy devices in the domestic market [9] - Huadong Medicine is actively working to introduce high-end energy source products to the domestic market, having already launched several products [9]