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FDA 510(k)

ZELTIQ SYSTEM

K-Number: K090094 · 2009-05-20

ApplicantZeltiq Aesthetics
Decision Date2009-05-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZELTIQ SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zeltiq Aesthetics. It received FDA 510(k) clearance on 2009-05-20 under 510(k) number K090094. 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 SYSTEM?

ZELTIQ SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-20. The listed applicant is Zeltiq Aesthetics. The 510(k) number is K090094.

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

ZELTIQ SYSTEM received FDA 510(k) clearance on 2009-05-20, under 510(k) number K090094.

Who is the listed applicant for ZELTIQ SYSTEM?

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 SYSTEM?

The FDA product code for ZELTIQ SYSTEM is GEX. This falls under the Gastroenterology category.

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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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Related Devices (Code: GEX)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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