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FDA 510(k)

Resonic Rapid Acoustic Pulse Device

K-Number: K222629 · 2022-09-25

ApplicantZeltiq Aesthetics, Inc.
Decision Date2022-09-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Resonic Rapid Acoustic Pulse Device 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 2022-09-25 under 510(k) number K222629. 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 Resonic Rapid Acoustic Pulse Device?

Resonic Rapid Acoustic Pulse Device is a medical device that received FDA 510(k) clearance on 2022-09-25. The listed applicant is Zeltiq Aesthetics, Inc.. The 510(k) number is K222629.

When did Resonic Rapid Acoustic Pulse Device receive FDA 510(k) clearance?

Resonic Rapid Acoustic Pulse Device received FDA 510(k) clearance on 2022-09-25, under 510(k) number K222629.

Who is the listed applicant for Resonic Rapid Acoustic Pulse Device?

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 Resonic Rapid Acoustic Pulse Device?

The FDA product code for Resonic Rapid Acoustic Pulse Device is GEX. This falls under the Gastroenterology category.

Other records listing Zeltiq Aesthetics, Inc. as applicant

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Related Devices (Code: GEX)

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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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