ZELTIQ 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 Zeltiq Coolsculpting System.

Pre-market Notification Details

Device IDK193566
510k NumberK193566
Device Name:ZELTIQ CoolSculpting System
ClassificationDermal Cooling Pack/vacuum/massager
Applicant ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive Pleasanton,  CA  94588
ContactTammy Wharton
CorrespondentTammy Wharton
ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive Pleasanton,  CA  94588
Product CodeOOK  
CFR Regulation Number878.4340 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-01-21

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