Cleared Traditional

K171135 - Lipogems System

K171135 is an FDA 510(k) clearance for Lipogems System, manufactured by Lipogems International Spa. The device is a Class 2 General & Plastic Surgery device with product code MUU cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K171135 · Lipogems International Spa · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2017
Decision
31d
Days
Class 2
Risk

K171135 is an FDA 510(k) clearance for the Lipogems System. Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Lipogems International Spa (Milano, IT). The FDA issued a Cleared decision on May 18, 2017 after a review of 31 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.

View all Lipogems International Spa devices

FDA 510(k) Submission Details - K171135

510(k) Number K171135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date May 18, 2017
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
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.