Fed Regist. 2011 Apr 14;76(72):20840-2.
The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser 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. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.
美国食品药品监督管理局（FDA）正在将用于美容的低水平激光系统归类为II类（特殊控制）。适用于该设备的特殊控制措施名为“II类特殊控制指南文件：用于美容的低水平激光系统”。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。在本期《联邦公报》的其他地方，FDA宣布可提供一份指南文件，该文件将作为此类设备的特殊控制措施。
