Cleared Traditional

K172714 - LipiVage

K172714 is an FDA 510(k) clearance for LipiVage, manufactured by Genesis Biosystems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MUU cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K172714 · Genesis Biosystems, Inc. · General & Plastic Surgery device
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Dec 2017
Decision
91d
Days
Class 2
Risk

K172714 is an FDA 510(k) clearance for the LipiVage. Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Genesis Biosystems, Inc. (Lewisville, US). The FDA issued a Cleared decision on December 8, 2017 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Genesis Biosystems, Inc. devices

FDA 510(k) Submission Details - K172714

510(k) Number K172714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2017
Decision Date December 08, 2017
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUU Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MUU System, Suction, Lipoplasty

All 12
Devices cleared under the same product code (MUU) and FDA review panel - the closest regulatory comparables to K172714.
KTA Adipose Treatment Kit
K190386 · Stemics S.A.S · Oct 2019
AuraGen 123 Suction Lipoplasty System (A123)
K190278 · Auragen Aesthetics, LLC · May 2019
Automatic Tissue Processing Unit
K172717 · Bsl Co. · May 2018
Alma LipoFlow System
K171242 · Alma Lasers, Inc. · Jul 2017
FAT CONCENTRATION SYSTEM
K100114 · Biomet, Inc. · Sep 2010