Cleared Traditional

K063336 - MEDELA DOMINANT 50 LIPO, MODEL 600-5706

K063336 is an FDA 510(k) clearance for MEDELA DOMINANT 50 LIPO, manufactured by Medela AG. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K063336 · Medela AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
112d
Days
Class 2
Risk

K063336 is an FDA 510(k) clearance for the MEDELA DOMINANT 50 LIPO, MODEL 600-5706. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Medela AG (Baar Zug, CH). The FDA issued a Cleared decision on February 26, 2007 after a review of 112 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.

View all Medela AG devices

FDA 510(k) Submission Details - K063336

510(k) Number K063336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date February 26, 2007
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
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 41
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K063336.
SUCTION LIPOLASTY ACCESSORIES
K113795 · Norman M. Black Iii · Aug 2012
SOUND SURGICAL VASER 2.1 LIPO SYSTEM
K110306 · Sound Surgical Technologies, LLC · Jun 2011
SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
K110255 · Sound Surgical Technologies, LLC · Apr 2011
MACROPORE PURICEL LIPOPLASTY SYSTEM
K042261 · Macropore Biosurgery, Inc. · Sep 2004
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
K041058 · Misonix, Inc. · May 2004
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
K004005 · Mentor Corp. · Oct 2001