ZELTIQ CoolSculpting System
K-Number: K183514 · 2019-01-14
ApplicantZeltiq Aesthetics, Inc.
Decision Date2019-01-14
Product CodeOOK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ZELTIQ CoolSculpting System is a medical device manufactured by Zeltiq Aesthetics, Inc.. It received FDA 510(k) clearance on 2019-01-14 under approval number K183514. The device is classified under product code OOK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ZELTIQ CoolSculpting System?
ZELTIQ CoolSculpting System is a medical device that received FDA 510(k) clearance on 2019-01-14. It is manufactured by Zeltiq Aesthetics, Inc.. The 510(k) number is K183514.
When was ZELTIQ CoolSculpting System approved by the FDA?
ZELTIQ CoolSculpting System received FDA 510(k) clearance on 2019-01-14, under approval number K183514.
What company makes ZELTIQ CoolSculpting System?
ZELTIQ CoolSculpting System is manufactured by Zeltiq Aesthetics, Inc..
What is the FDA product code for ZELTIQ CoolSculpting System?
The FDA product code for ZELTIQ CoolSculpting System is OOK.
Other Devices by Zeltiq Aesthetics, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.