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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR878.4590]
See Related Information on Focused ultrasound stimulator system for aesthetic use. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES

Subpart E--Surgical Devices

Sec. 878.4590 Focused ultrasound stimulator system for aesthetic use.

(a)Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is 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 noninvasive aesthetic use.

(b)Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use." See 878.1(e) for the availability of this guidance document.

[76 FR 43121, July 20, 2011]

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