Cleared Traditional

K063235 - CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT

K063235 is an FDA 510(k) clearance for CYTORI LIPOPLASTY SYSTEM WITH CELASE RE..., manufactured by Cytori Therapeutics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K063235 · Cytori Therapeutics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
91d
Days
Class 2
Risk

K063235 is an FDA 510(k) clearance for the CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Cytori Therapeutics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 24, 2007 after a review of 91 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 - K063235

510(k) Number K063235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2006
Decision Date January 24, 2007
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
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 K063235.
LIPO CANNULA
K081039 · Millennium Medical Technologies, Inc. · Jul 2008
LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688
K072793 · Moeller Medical GmbH & Co. KG · Mar 2008
MEDELA DOMINANT 50 LIPO, MODEL 600-5706
K063336 · Medela AG · Feb 2007
LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274
K053451 · Moeller Medical GmbH & Co. KG · Aug 2006
TULIP DISPOSABLE CANNULAS
K060089 · Cell Bio-Systems, Inc. · Apr 2006
SORING GMBH SONOCA LIPO
K052183 · Soring GmbH Medizintechnik · Oct 2005