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FDA 510(k)

ZELTIQ CoolSculpting System

K-Number: K162050 · 2016-11-21

ApplicantZeltiq Aesthetics, Inc.
Decision Date2016-11-21
Product CodeOOK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZELTIQ CoolSculpting 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 2016-11-21 under 510(k) number K162050. 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 System?

ZELTIQ CoolSculpting System is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Zeltiq Aesthetics, Inc.. The 510(k) number is K162050.

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

ZELTIQ CoolSculpting System received FDA 510(k) clearance on 2016-11-21, under 510(k) number K162050.

Who is the listed applicant for ZELTIQ CoolSculpting 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 ZELTIQ CoolSculpting System?

The FDA product code for ZELTIQ CoolSculpting System is OOK.

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

View all 10 devices →

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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