医疗器械；普通外科和整形外科器械；用于改善橘皮组织外观的动力外科器械的分类。最终命令。

Medical devices; general and plastic surgery devices; classification of the powered surgical instrument for improvement in the appearance of cellulite. Final order.

出版信息

Fed Regist. 2014 Jun 3;79(106):31859-61.

Abstract

The Food and Drug Administration (FDA) is classifying the powered surgical instrument for improvement in the appearance of cellulite into class II (special controls). 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.

摘要

美国食品药品监督管理局（FDA）正在将用于改善橘皮组织外观的电动手术器械归类为II类（特殊控制）。该机构将该器械归类为II类（特殊控制），以便合理保证该器械的安全性和有效性。

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