Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4590
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.