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FDA 510(k)

ZELTIQ COOLSCULPTING

K-Number: K120023 · 2012-05-02

ApplicantZeltiq Aesthetics, Inc.
Decision Date2012-05-02
Product CodeOOK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZELTIQ COOLSCULPTING 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 2012-05-02 under 510(k) number K120023. 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?

ZELTIQ COOLSCULPTING is a medical device that received FDA 510(k) clearance on 2012-05-02. The listed applicant is Zeltiq Aesthetics, Inc.. The 510(k) number is K120023.

When did ZELTIQ COOLSCULPTING receive FDA 510(k) clearance?

ZELTIQ COOLSCULPTING received FDA 510(k) clearance on 2012-05-02, under 510(k) number K120023.

Who is the listed applicant for ZELTIQ COOLSCULPTING?

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 ZELTIQ COOLSCULPTING?

The FDA product code for ZELTIQ COOLSCULPTING is OOK.

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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 DeviceK212707CoolSculpting Elite SystemK193566ZELTIQ CoolSculpting SystemK183514ZELTIQ CoolSculpting SystemK181740ZELTIQ CoolSculpting 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 AestheticsK212707CoolSculpting Elite SystemZeltiq Aesthetics, Inc.K193566ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K183514ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.K172144CoolSculpting SystemZeltiq Aesthetics

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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