Cleared Traditional

K081039 - LIPO CANNULA

K081039 is an FDA 510(k) clearance for LIPO CANNULA, manufactured by Millennium Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K081039 · Millennium Medical Technologies, Inc. · General & Plastic Surgery device
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Jul 2008
Decision
90d
Days
Class 2
Risk

K081039 is an FDA 510(k) clearance for the LIPO CANNULA. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Millennium Medical Technologies, Inc. (Laverne, US). The FDA issued a Cleared decision on July 10, 2008 after a review of 90 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.

FDA 510(k) Submission Details - K081039

510(k) Number K081039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2008
Decision Date July 10, 2008
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPB Device Classification - Class 2, Special Controls

Product Code QPB System, Suction, Lipoplasty For Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5040
Definition A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring
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 - QPB System, Suction, Lipoplasty For Removal

All 59
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K081039.
LIPOSE DISPOSABLE CANNULA
K093067 · Lipose Corp. · Dec 2009
BODY-JET
K082025 · Human Med AG · Aug 2008
POWER ASPIRATOR, MODEL LS2 OR LS2DP
K081593 · Medical Device Resource Corp. · Jul 2008
LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688
K072793 · Moeller Medical GmbH & Co. KG · Mar 2008
MEDELA DOMINANT 50 LIPO, MODEL 600-5706
K063336 · Medela AG · Feb 2007
CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
K063235 · Cytori Therapeutics, Inc. · Jan 2007