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U.S. Department of Health and Human Services

Radiation Emitting Electronic Product Codes
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Productfocused ultrasound for tissue heat or mechanical cellular disruption
Regulation DescriptionFocused ultrasound stimulator system for aesthetic use.
Definition
A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.
Product Description General & Plastic Surgery Ultrasonic Medical Devices (Miscellaneous)
Product CodeOHV
Radiation Type Acoustic
Radiation Safety Report Type Required? None
Annual Reports Required? No
Regulation Number 878.4590
Applicable Performance Standard(s) No standard applicable. General Radiological Health requirements apply. [1000-1005]

Guidance Document
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