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FDA 510(k)

ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE

K-Number: K080118 · 2008-05-02

ApplicantZeltiq Aesthetics
Decision Date2008-05-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Zeltiq Aesthetics. It received FDA 510(k) clearance on 2008-05-02 under 510(k) number K080118. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE?

ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Zeltiq Aesthetics. The 510(k) number is K080118.

When did ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE receive FDA 510(k) clearance?

ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE received FDA 510(k) clearance on 2008-05-02, under 510(k) number K080118.

Who is the listed applicant for ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE?

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

What is the FDA product code for ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE?

The FDA product code for ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Zeltiq Aesthetics 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.

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Official Source

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