Cleared Traditional

K190278 - AuraGen 123 Suction Lipoplasty System (A123) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190278 · Auragen Aesthetics, LLC · General & Plastic Surgery device
May 2019
Decision
84d
Days
Class 2
Risk

K190278 is an FDA 510(k) clearance for the AuraGen 123 Suction Lipoplasty System (A123). Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Auragen Aesthetics, LLC (Weston, US). The FDA issued a Cleared decision on May 3, 2019 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5040 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K190278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2019
Decision Date May 03, 2019
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 132d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUU System, Suction, Lipoplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5040
Definition See Federal Register Notice At 86 Fr 50887 “consolidation Of Devices That Process Autologous Human Cells, Tissues, And Cellular And Tissue-based Products At The Point Of Care To Produce A Therapeutic Article” (frn) (fda-2021-n-0881).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.