AuraGen 123 Suction Lipoplasty System (A123)

System, Suction, Lipoplasty

AuraGen Aesthetics LLC

The following data is part of a premarket notification filed by Auragen Aesthetics Llc with the FDA for Auragen 123 Suction Lipoplasty System (a123).

Pre-market Notification Details

Device IDK190278
510k NumberK190278
Device Name:AuraGen 123 Suction Lipoplasty System (A123)
ClassificationSystem, Suction, Lipoplasty
Applicant AuraGen Aesthetics LLC 11 Dellbrook Road Weston,  MA  02493
ContactYiannis Monovoukas
CorrespondentRandy J. Prebula
Hogan Lovells US LLP 555 Thirteenth Street, NW Washington,  DC  20004
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-08
Decision Date2019-05-03

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