Product code OOK

Device name

Dermal Cooling Pack/Vacuum/Massager

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4340

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset