OOK · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4340
Classification
FDA Product Code
OOK
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4340
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.