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Dermal Cooling Pack/Vacuum/Massager

FDA product code OOK · 10 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4340
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2012-05-02 – 2024-09-12

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.

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