Cleared Traditional

K093067 - LIPOSE DISPOSABLE CANNULA

K093067 is an FDA 510(k) clearance for LIPOSE DISPOSABLE CANNULA, manufactured by Lipose Corp.. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K093067 · Lipose Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
90d
Days
Class 2
Risk

K093067 is an FDA 510(k) clearance for the LIPOSE DISPOSABLE CANNULA. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Lipose Corp. (Santa Barbara, US). The FDA issued a Cleared decision on December 29, 2009 after a review of 90 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.

FDA 510(k) Submission Details - K093067

510(k) Number K093067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date December 29, 2009
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 59
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K093067.
SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
K110255 · Sound Surgical Technologies, LLC · Apr 2011
EUROMI EVA SP6
K101413 · Euromi S.A · Dec 2010
PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE
K092066 · Andrew Technologies, LLC · Apr 2010
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
K093067 · LIPOSE DISPOSABLE CANNULA
Download PDF FDA Summary Lipose Corp.