Cleared Special

LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 (K092284) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K092284 · Medical Device Resource Corp. · General & Plastic Surgery device
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Sep 2009
Decision
34d
Days
Class 2
Risk

K092284 is an FDA 510(k) clearance for the LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200. Classified as System, Suction, Lipoplasty (product code MUU), Class II - Special Controls.

Submitted by Medical Device Resource Corp. (Hayward, US). The FDA issued a Cleared decision on September 1, 2009 after a review of 34 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Device Resource Corp. devices

Submission Details

510(k) Number K092284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date September 01, 2009
Days to Decision 34 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - MUU System, Suction, Lipoplasty

All 39
Devices cleared under the same product code (MUU) and FDA review panel - the closest regulatory comparables to K092284.
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