光电设备用于皮肤光老化及皱纹治疗的概况及审评关注点

Overview and Evaluation Concerns of Optical and Electrical Devices for Skin Photoaging and Wrinkle Treatment

对皮肤光老化及皱纹治疗的光电类设备的作用机制、产品类型进行梳理,并结合已获医疗器械注册证设备的性能参数、适用范围等批准情况及最新发布的指导原则,提出并总结此类产品的审评关注点。以期对该类产品的监管提供参考。

This paper reviews the mechanism of action and product types of optical and electronic devices for skin photoaging and wrinkle treatment,and puts forward and summarizes the review concerns of such products based on the approval of the performance parameters and scope of application of the equipment that has obtained the medical device registration certificate and the newly released guidance.In order to provide reference for the supervision of these products.