title: Medical devices; general and plastic surgery devices; classification of the focused ultrasound stimulator system for aesthetic use. Final rule.
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.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D057086:High-Intensity Focused Ultrasound Ablation / Q000009:adverse effects / Q000145:classification / Q000295:instrumentation*; D006801:Humans; D013518:Surgery, Plastic / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D014464:Ultrasonic Therapy / Q000009:adverse effects / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration