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FDA 510(k)

AuraGen 123 Suction Lipoplasty System (A123)

K-Number: K190278 · 2019-05-03

ApplicantAuragen Aesthetics, LLC
Decision Date2019-05-03
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AuraGen 123 Suction Lipoplasty System (A123) is the device name listed in this FDA 510(k) record. The listed applicant is Auragen Aesthetics, LLC. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190278. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AuraGen 123 Suction Lipoplasty System (A123)?

AuraGen 123 Suction Lipoplasty System (A123) is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Auragen Aesthetics, LLC. The 510(k) number is K190278.

When did AuraGen 123 Suction Lipoplasty System (A123) receive FDA 510(k) clearance?

AuraGen 123 Suction Lipoplasty System (A123) received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190278.

Who is the listed applicant for AuraGen 123 Suction Lipoplasty System (A123)?

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

What is the FDA product code for AuraGen 123 Suction Lipoplasty System (A123)?

The FDA product code for AuraGen 123 Suction Lipoplasty System (A123) is MUU.

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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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