Cleared Traditional

K004005 - MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)

K004005 is an FDA 510(k) clearance for MENTOR ULTRASOUND-ASSISTED TISSUE REMOV..., manufactured by Mentor Corp.. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K004005 · Mentor Corp. · General & Plastic Surgery device
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Oct 2001
Decision
290d
Days
Class 2
Risk

K004005 is an FDA 510(k) clearance for the MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GE.... Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on October 12, 2001 after a review of 290 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. 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 Mentor Corp. devices

FDA 510(k) Submission Details - K004005

510(k) Number K004005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date October 12, 2001
Days to Decision 290 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
175d slower than avg
Panel avg: 115d · This submission: 290d
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 49
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K004005.
SORING GMBH SONOCA LIPO
K052183 · Soring GmbH Medizintechnik · Oct 2005
MACROPORE PURICEL LIPOPLASTY SYSTEM
K042261 · Macropore Biosurgery, Inc. · Sep 2004
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
K041058 · Misonix, Inc. · May 2004
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
K010666 · Medtronic Xomed, Inc. · May 2001
ACCELERATOR RECIPROCATING CANNULA
K001803 · Byron Medical · Aug 2000
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
K992855 · Xomed, Inc. · Jan 2000