# Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound Stimulator System for Aesthetic Use
> **Food and Drug Administration** · Final rule. · Published 2011-07-20 · Effective 2011-08-19 · 76 FR 43119
## Document
- **Document number:** 2011-18278
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 43119
- **CFR reference:** 21 CFR 878
- **Publication date:** 2011-07-20
- **Effective date:** 2011-08-19
- **HHS docket:** Docket No. FDA-2011-N-0499
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/07/20/2011-18278/medical-devices-general-and-plastic-surgery-devices-classification-of-the-focused-ultrasound)
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