Cleared Traditional

K004005 - MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

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Submission Details

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
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 114d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K004005.
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