FDA 510(k), K160259, ZELTIQ CoolSculpting System

FDA 510(k), K160259, ZELTIQ CoolSculpting System

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510(K) Number: K160259
Device Name: ZELTIQ CoolSculpting System
Manufacturer: SHRUTI JAYAKUMAR
Device Classification Name: Dermal Cooling Pack/Vacuum/Massager
Regulation Number: OOK
Classification Product Code: 02/01/2016
Date Received: 03/23/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

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