federal_register: 2011-18278

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2011-18278 Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound Stimulator System for Aesthetic Use Rule 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. 2011-07-20 2011 7 https://www.federalregister.gov/documents/2011/07/20/2011-18278/medical-devices-general-and-plastic-surgery-devices-classification-of-the-focused-ultrasound https://www.govinfo.gov/content/pkg/FR-2011-07-20/pdf/2011-18278.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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