OOK

Dermal Cooling Pack/Vacuum/Massager

Product code: OOK
Device name: Dermal Cooling Pack/Vacuum/Massager
Device class: Class 2
21 CFR: 21 CFR 878.4340
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 14

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-09-12.

Number	Decision date	Applicant	Device name	Summary
K233732	2024-09-12	Zeltiq Aesthetics, Inc. (Acquired by A	CoolSculpting Elite System	PDF

1 summaries are archived here for direct download.

Official FDA classification page: OOK

Classification and pathway per current FDA publications. Data from openFDA (CC0).