Cleared Traditional

K163647 - Revolve Envi 600 Advanced Adipose System

K163647 is an FDA 510(k) clearance for Revolve Envi 600 Advanced Adipose System, manufactured by Lifecell Corporation. The device is a Class 2 General & Plastic Surgery device with product code MUU cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K163647 · Lifecell Corporation · General & Plastic Surgery device
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Aug 2017
Decision
245d
Days
Class 2
Risk

K163647 is an FDA 510(k) clearance for the Revolve Envi 600 Advanced Adipose System. Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Lifecell Corporation (Branchburg, US). The FDA issued a Cleared decision on August 25, 2017 after a review of 245 days - an extended review 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: 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 Lifecell Corporation devices

FDA 510(k) Submission Details - K163647

510(k) Number K163647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date August 25, 2017
Days to Decision 245 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 115d · This submission: 245d
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 31
Devices cleared under the same product code (MUU) and FDA review panel - the closest regulatory comparables to K163647.
AuraGen 123 Suction Lipoplasty System (A123)
K190278 · Auragen Aesthetics, LLC · May 2019
Automatic Tissue Processing Unit
K172717 · Bsl Co. · May 2018
LipiVage
K172714 · Genesis Biosystems, Inc. · Dec 2017
Alma LipoFlow System
K171242 · Alma Lasers, Inc. · Jul 2017
Lipogems System
K171135 · Lipogems International Spa · May 2017
Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
K170449 · Millennium Medical Technologies, Inc. · Mar 2017