AuraGen 123 Suction Lipoplasty System (A123)— 510(k) K190278

Name: FDA 510(k) clearance K190278
Creator: U.S. Food and Drug Administration
Published: 2019-05-03

Substantially Equivalent

Auragen Aesthetics, LLC

FDA 510(k) clearance K190278 for AuraGen 123 Suction Lipoplasty System (A123), Substantially Equivalent on 2019-05-03. Applicant: Auragen Aesthetics, LLC. Device class: 2.

Clearance details

Applicant: Auragen Aesthetics, LLC
Product code: Code MUU
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2019-02-08
Decision date: 2019-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, MA, US

Download summary PDF View on FDA.gov ↗

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