FDA product code OHV

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

General, Plastic Surgery·Class 2·21 CFR 878.4590
US regulatory classifications
US Product Code (FDA)
OHV
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4590
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not 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.

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About this record

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.