3A类半导体激光治疗仪的作用机理研究  

Study on the Mechanism of Class IIIa Semiconductor Laser Medical Devices

作　　者：李非[1,2] 李竹 杨牧 迟戈 

机构地区：[1]辽宁省食品药品监督管理局技术审评中心,沈阳110003 [2]沈阳药科大学,沈阳110016

出　　处：《中国医疗器械信息》2013年第8期46-50,共5页China Medical Device Information

摘　　要：目的:研究3A类半导体激光治疗仪的作用机理和医学应用,以规范和明确该类产品的预期用途,降低产品使用风险。方法:对我国医学专业文献进行综述研究,并结合美国FDA半导体激光产品的技术指导原则,分析研究3A类半导体激光的工作原理、生物效应、作用机理。结论:对于3A类半导体激光治疗设备,具有较为成熟机理和临床研究数据支持的医学应用主要是血管外照射和镇痛。为降低上市产品风险,可采用规范临床试验审评、加强质量体系控制和加强上市后监测等监管措施。Objective： This article aim to study the mechanism of class Ilia semiconductor laser medical devices, thus clarify the intended uses of such products. Methods： Based on FDA regulation and literature research, an analysis is carried out on the principle, mechanism and clinical application of c^ass Ilia semiconductor laser medical devices. Conclusions： Baesd on clinical studies and mechanism research, the intended uses of class IIla semiconductor laser medical devices should be extravascular irradiation therapeutics and pain-alleviating. Specific regulation methods should be adopted to reduce risks, such as enhanced clinical study evaluation, quality management system and post-market surveillance.

关 键 词：3A类 半导体激光治疗仪 作用机理 血管外照射 镇痛 

分 类 号：R454.2[医药卫生—治疗学]