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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dermal cooling pack/vacuum/massager
510(k) Number K151179
Device Name ZELTIQ CoolSculpting System
Applicant
ZELTIQ AESTHETICS, INC.
4698 WILLOW ROAD
PLEASANTON,  CA  94588
Applicant Contact SHRUTI JAYAKUMAR
Correspondent
ZELTIQ AESTHETICS, INC.
4698 WILLOW ROAD
PLEASANTON,  CA  94588
Correspondent Contact SHRUTI JAYAKUMAR
Regulation Number878.4340
Classification Product Code
OOK  
Date Received05/04/2015
Decision Date 09/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01859091
NCT02298322
Reviewed by Third Party No
Combination Product No
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