ZELTIQ SYSTEM

Powered Laser Surgical Instrument

ZELTIQ AESTHETICS

The following data is part of a premarket notification filed by Zeltiq Aesthetics with the FDA for Zeltiq System.

Pre-market Notification Details

Device IDK090094
510k NumberK090094
Device Name:ZELTIQ SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant ZELTIQ AESTHETICS 4698 WILLOW ROAD Pleasanton,  CA  94588
ContactDonald V Johnson
CorrespondentDonald V Johnson
ZELTIQ AESTHETICS 4698 WILLOW ROAD Pleasanton,  CA  94588
Product CodeGEX  
Subsequent Product CodeILO
Subsequent Product CodeISA
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-14
Decision Date2009-05-20
Summary:summary

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