Cleared Special

K072793 - LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688

K072793 is an FDA 510(k) clearance for LIPOSAT BASIC (INFILTRATION PUMP), manufactured by Moeller Medical GmbH & Co. KG. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Special 510(k) pathway after a 155-day FDA review.

K072793 · Moeller Medical GmbH & Co. KG · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
155d
Days
Class 2
Risk

K072793 is an FDA 510(k) clearance for the LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Moeller Medical GmbH & Co. KG (Coto De Caza, US). The FDA issued a Cleared decision on March 4, 2008 after a review of 155 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072793

510(k) Number K072793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2007
Decision Date March 04, 2008
Days to Decision 155 days
Submission Type Special
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
40d slower than avg
Panel avg: 115d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

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 K072793.
BODY-JET
K082025 · Human Med AG · Aug 2008
POWER ASPIRATOR, MODEL LS2 OR LS2DP
K081593 · Medical Device Resource Corp. · Jul 2008
LIPO CANNULA
K081039 · Millennium Medical Technologies, Inc. · Jul 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
LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274
K053451 · Moeller Medical GmbH & Co. KG · Aug 2006
K072793 · LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688
Download PDF FDA Summary Moeller Medical GmbH …