ZEL TIQ CoolSculpting 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 Zel Tiq Coolsculpting System.

Pre-market Notification Details

Device IDK142491
510k NumberK142491
Device Name:ZEL TIQ CoolSculpting System
ClassificationDermal Cooling Pack/vacuum/massager
Applicant ZELTIQ AESTHETICS, INC. 4698 WILLOW ROAD Pleasanton,  CA  94588
ContactShruti Jayakumar
CorrespondentShruti Jayakumar
ZELTIQ AESTHETICS, INC. 4698 WILLOW ROAD Pleasanton,  CA  94588
Product CodeOOK  
CFR Regulation Number878.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-04
Decision Date2015-01-26
Summary:summary

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