CoolSculpting Elite System

Dermal Cooling Pack/vacuum/massager

Zeltiq Aesthetics, Inc.

The following data is part of a premarket notification filed by Zeltiq Aesthetics, Inc. with the FDA for Coolsculpting Elite System.

Pre-market Notification Details

Device IDK212707
510k NumberK212707
Device Name:CoolSculpting Elite System
ClassificationDermal Cooling Pack/vacuum/massager
Applicant Zeltiq Aesthetics, Inc. 4410 Rosewood Drive Pleasanton,  CA  94588
ContactVicky Chai
CorrespondentVicky Chai
Zeltiq Aesthetics, Inc. 4410 Rosewood Drive Pleasanton,  CA  94588
Product CodeOOK  
CFR Regulation Number878.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-26
Decision Date2021-11-05

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