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OOK — Dermal Cooling Pack/Vacuum/Massager Class II

FDA Device Classification

Classification Details

Product Code
OOK
Device Class
Class II
Regulation Number
878.4340
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233732zeltiq aesthetics, inc. (acquired by allergan aestheticsCoolSculpting Elite SystemSeptember 12, 2024
K212707zeltiq aestheticsCoolSculpting Elite SystemNovember 5, 2021
K193566zeltiq aestheticsZELTIQ CoolSculpting SystemJanuary 21, 2020
K183514zeltiq aestheticsZELTIQ CoolSculpting SystemJanuary 14, 2019
K181740zeltiq aestheticsZELTIQ CoolSculpting SystemAugust 29, 2018
K172144zeltiq aestheticsCoolSculpting SystemNovember 1, 2017
K171069zeltiq aestheticsZELTIQ CoolSculpting SystemJuly 7, 2017
K162050zeltiq aestheticsZELTIQ CoolSculpting SystemNovember 21, 2016
K160259zeltiq aestheticsZELTIQ CoolSculpting SystemMarch 23, 2016
K151179zeltiq aestheticsZELTIQ CoolSculpting SystemSeptember 22, 2015
K142491zeltiq aestheticsZEL TIQ CoolSculpting SystemJanuary 26, 2015
K133212zeltiq aestheticsZELTIQ COOLSCULPTING SYSTEMApril 9, 2014
K120023zeltiq aestheticsZELTIQ COOLSCULPTINGMay 2, 2012
DEN090002zeltiq aestheticsZELTIQ AESTHETICS DERMAL COOLING DEVICEAugust 24, 2010