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FDA 510(k)

ACNELIFT

K-Number: K041103 · 2004-07-27

ApplicantInner Act, LLC
Decision Date2004-07-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACNELIFT is the device name listed in this FDA 510(k) record. The listed applicant is Inner Act, LLC. It received FDA 510(k) clearance on 2004-07-27 under 510(k) number K041103. 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 ACNELIFT?

ACNELIFT is a medical device that received FDA 510(k) clearance on 2004-07-27. The listed applicant is Inner Act, LLC. The 510(k) number is K041103.

When did ACNELIFT receive FDA 510(k) clearance?

ACNELIFT received FDA 510(k) clearance on 2004-07-27, under 510(k) number K041103.

Who is the listed applicant for ACNELIFT?

The FDA 510(k) record lists Inner Act, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACNELIFT?

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

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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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