Cleared Traditional

K031881 - AIRBRUSH LIPOSCULPTOR SYSTEM

K031881 is an FDA 510(k) clearance for AIRBRUSH LIPOSCULPTOR SYSTEM, manufactured by Biosculpture Technology, Inc.. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K031881 · Biosculpture Technology, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
40d
Days
Class 2
Risk

K031881 is an FDA 510(k) clearance for the AIRBRUSH LIPOSCULPTOR SYSTEM. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Biosculpture Technology, Inc. (New York, US). The FDA issued a Cleared decision on July 28, 2003 after a review of 40 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.

FDA 510(k) Submission Details - K031881

510(k) Number K031881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2003
Decision Date July 28, 2003
Days to Decision 40 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 115d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
N.E. DEVINE, JR.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K031881.
MACROPORE PURICEL LIPOPLASTY SYSTEM
K042261 · Macropore Biosurgery, Inc. · Sep 2004
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
K041058 · Misonix, Inc. · May 2004
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
K032802 · Hk Surgical, Inc. · Nov 2003
SOUNDVASER SYSTEM
K022051 · Sound Surgical Technologies, LLC · Sep 2002
STARS2000 POWER CANNULA
K012236 · Kmi Kolster Methods, Inc. · Nov 2001
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
K004005 · Mentor Corp. · Oct 2001

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K031881 · AIRBRUSH LIPOSCULPTOR SYSTEM
Download PDF FDA Summary Biosculpture Technolo…