DeviceClearance

Product code OOK— General, Plastic Surgery

ZELTIQ CoolSculpting System

Classification name
Dermal Cooling Pack/Vacuum/Massager
Device class
Class 2
Regulation
21 CFR 878.4340
Advisory panel
General, Plastic Surgery
Total cleared
14
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OOK under 21 CFR 878.4340, via openFDA

Market context for product code OOK

FDA has cleared 14 devices under product code OOK between 2010 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OOK

Adverse events under product code OOK

product code OOK
Injury
10,813
Total
10,813

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OOK

Data sourced from openFDA. This site is unofficial and independent of the FDA.