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FDA 510(k)

CoolSculpting System

K-Number: K172144 · 2017-11-01

ApplicantZeltiq Aesthetics
Decision Date2017-11-01
Product CodeOOK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CoolSculpting System is a medical device manufactured by Zeltiq Aesthetics. It received FDA 510(k) clearance on 2017-11-01 under approval number K172144. 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 CoolSculpting System?

CoolSculpting System is a medical device that received FDA 510(k) clearance on 2017-11-01. It is manufactured by Zeltiq Aesthetics. The 510(k) number is K172144.

When was CoolSculpting System approved by the FDA?

CoolSculpting System received FDA 510(k) clearance on 2017-11-01, under approval number K172144.

What company makes CoolSculpting System?

CoolSculpting System is manufactured by Zeltiq Aesthetics.

What is the FDA product code for CoolSculpting System?

The FDA product code for CoolSculpting System is OOK.

Related Devices (Code: OOK)

K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. K183514ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. K193566ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.

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.

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