Cleared Traditional

K042261 - MACROPORE PURICEL LIPOPLASTY SYSTEM (FDA 510(k) Clearance)

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

K042261 · Macropore Biosurgery, Inc. · General & Plastic Surgery device
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Sep 2004
Decision
28d
Days
Class 2
Risk

K042261 is an FDA 510(k) clearance for the MACROPORE PURICEL LIPOPLASTY SYSTEM. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Macropore Biosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on September 20, 2004 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Macropore Biosurgery, Inc. devices

Submission Details

510(k) Number K042261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2004
Decision Date September 20, 2004
Days to Decision 28 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
86d faster than avg
Panel avg: 114d · This submission: 28d
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
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