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FDA 510(k)

CoolSculpting Elite System

K-Number: K212707 · 2021-11-05

ApplicantZeltiq Aesthetics, Inc.
Decision Date2021-11-05
Product CodeOOK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CoolSculpting Elite System is a medical device manufactured by Zeltiq Aesthetics, Inc.. It received FDA 510(k) clearance on 2021-11-05 under approval number K212707. 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 Elite System?

CoolSculpting Elite System is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Zeltiq Aesthetics, Inc.. The 510(k) number is K212707.

When was CoolSculpting Elite System approved by the FDA?

CoolSculpting Elite System received FDA 510(k) clearance on 2021-11-05, under approval number K212707.

What company makes CoolSculpting Elite System?

CoolSculpting Elite System is manufactured by Zeltiq Aesthetics, Inc..

What is the FDA product code for CoolSculpting Elite System?

The FDA product code for CoolSculpting Elite System is OOK.

Related Clinical Trials

NCT06783621 A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products COMPLETED NCT06872684 Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD) RECRUITING

Other Devices by Zeltiq Aesthetics, Inc.

K162050ZELTIQ CoolSculpting System K160259ZELTIQ CoolSculpting System K171069ZELTIQ CoolSculpting System K181740ZELTIQ CoolSculpting System K183514ZELTIQ CoolSculpting System K193566ZELTIQ CoolSculpting System

View all 9 devices →

Related Devices (Code: OOK)

K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. K172144CoolSculpting SystemZeltiq Aesthetics K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. K183514ZELTIQ 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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