医疗美容类激光设备适用范围的审评要点  

Concerns in the Review of the Application Scope of Medical Cosmetology Laser Equipment

作　　者：邱宏 申高 刘柏东 Qiu Hong;Shen Gao;Liu Bodong(Center for Medical Device Evaluation.NMPA,Beijing 100081,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100081

出　　处：《医疗装备》2023年第17期37-40,共4页Medical Equipment

摘　　要：医疗美容类激光设备的适用范围与该类设备作用于人体的机制密切相关。该研究从医疗器械审评角度总结医疗美容类激光设备的适用范围,为注册人和技术审评部门科学、合理地评价该类设备的安全性和有效性提供参考。The application scope of medical cosmetology laser equipment is closely related to the mechanism of this kind of equipment acting on the human body.In this paper,from the perspective of medical device review,the scope of application of medical cosmetology laser equipment was summarized to provide reference for the registrant and the technical review department to scientifically and reasonably evaluate the safety and effectiveness of this type of equipment.

关 键 词：医疗美容 激光设备 适用范围 技术审评 

分 类 号：R19[医药卫生—卫生事业管理]