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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 the device name listed in this FDA 510(k) record. The listed applicant is Zeltiq Aesthetics, Inc.. It received FDA 510(k) clearance on 2021-11-05 under 510(k) 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. The listed applicant is Zeltiq Aesthetics, Inc.. The 510(k) number is K212707.

When did CoolSculpting Elite System receive FDA 510(k) clearance?

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

Who is the listed applicant for CoolSculpting Elite System?

The FDA 510(k) record lists Zeltiq Aesthetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoolSculpting Elite System?

The FDA product code for CoolSculpting Elite System is OOK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07122583A Study to Assess Non-Invasive Subcutaneous Fat Reduction in the Submental, Inner Thigh and Back/Bra Areas With the CoolSculpting Elite SystemCOMPLETED

Other records listing Zeltiq Aesthetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233804Resonic Rapid Acoustic Pulse DeviceK222629Resonic Rapid Acoustic Pulse DeviceK193566ZELTIQ CoolSculpting SystemK183514ZELTIQ CoolSculpting SystemK181740ZELTIQ CoolSculpting SystemK172144CoolSculpting System

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Related Devices (Code: OOK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233732CoolSculpting Elite SystemZeltiq Aesthetics, Inc. (Acquired by Allergan AestheticsK193566ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K183514ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K172144CoolSculpting SystemZeltiq AestheticsK171069ZELTIQ 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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