Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
OHV · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4590
Classification
FDA Product Code
OHV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4590
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.