Fed Regist. 2011 Jul 20;76(139):43119-21.
The Food and Drug Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
美国食品药品监督管理局（FDA）正在将用于美容用途的聚焦超声刺激器系统归类为II类（特殊控制）。适用于该设备的特殊控制措施是题为《II类特殊控制指南文件：用于美容用途的聚焦超声刺激器系统》的指南文件。该机构将该设备归类为II类（特殊控制），以便合理保证该设备的安全性和有效性。
