ZELTIQ AESTHETICS DERMAL COOLING DEVICE

Dermal Cooling Pack/vacuum/massager

ZELTIQ AESTHETICS

The following data is part of a De Novo classification by Zeltiq Aesthetics with the FDA for Zeltiq Aesthetics Dermal Cooling Device.

Pre-market Notification Details

DeNovo IDDEN090002
Device Name:ZELTIQ AESTHETICS DERMAL COOLING DEVICE
ClassificationDermal Cooling Pack/vacuum/massager
Applicant ZELTIQ AESTHETICS 4698 Willow Road Pleasanton,  CA  94588
ContactLouis-pierre Marcoux
Product CodeOOK  
CFR Regulation Number878.4340 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK080521
Review Advisory BoardGeneral & Plastic Surgery
Classification AdvisoryGeneral & Plastic Surgery
TypePost-NSE
Date Received2009-10-13
Decision Date2010-08-24
Reclassification Order:Reclassification Order

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