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Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

FDA product code OHV · 26 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4590
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2011-08-19 – 2026-05-21

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.

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