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FDA 510(k)

CoolSculpting Elite System

K-Number: K233732 · 2024-09-12

ApplicantZeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics
Decision Date2024-09-12
Product CodeOOK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CoolSculpting Elite System is a medical device manufactured by Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics. It received FDA 510(k) clearance on 2024-09-12 under approval number K233732. 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 2024-09-12. It is manufactured by Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics. The 510(k) number is K233732.

When was CoolSculpting Elite System approved by the FDA?

CoolSculpting Elite System received FDA 510(k) clearance on 2024-09-12, under approval number K233732.

What company makes CoolSculpting Elite System?

CoolSculpting Elite System is manufactured by Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics.

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

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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