智通财经APP讯,华东医药(000963.SZ)发布公告,2025年3月5日,公司全资子公司Viora Ltd.(以下简称“Viora”)收到国家药品监督管理局(NMPA)签发的《受理通知书》,其申报的三类医疗器械光学射频治疗仪V30注册申请获得受理。
据悉,V30是Sinclair的全资子公司Viora开发的集射频(RF)、强脉冲光(IPL)、Nd:YAG激光能量源为一体的医美多功能操作平台,拥有 CORE™双极射频、PCR™强脉冲光专有技术,可搭载V-IPL强脉冲光手柄)、V-ST射频手柄、V-Nd:YAG激光手柄,能根据不同人群、不同肤质问题,灵活搭配专属治疗方案,提供面部及身体的全面解决方案,拟用于皮肤紧致、脱毛、血管和色素病变、痤疮等。V系列产品兼容性强,可适配未来Viora开发的新技术。V30已获得美国FDA、欧盟 CE注册认证。
本次V30顺利完成注册受理,是其在中国注册进程中的又一个重大里程碑,公司后续将继续积极推进这款产品在中国的注册工作,推动其早日在国内上市。
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