Cleared Traditional

K113795 - SUCTION LIPOLASTY ACCESSORIES

K113795 is an FDA 510(k) clearance for SUCTION LIPOLASTY ACCESSORIES, manufactured by Norman M. Black Iii. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K113795 · Norman M. Black Iii · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
228d
Days
Class 2
Risk

K113795 is an FDA 510(k) clearance for the SUCTION LIPOLASTY ACCESSORIES. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Norman M. Black Iii (Atlanta, US). The FDA issued a Cleared decision on August 7, 2012 after a review of 228 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.

View all Norman M. Black Iii devices

FDA 510(k) Submission Details - K113795

510(k) Number K113795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2011
Decision Date August 07, 2012
Days to Decision 228 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
113d slower than avg
Panel avg: 115d · This submission: 228d
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 26
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K113795.
VASERlipo System
K190551 · Solta Medical · May 2019
PowerX Lipo System
K190555 · Solta Medical · May 2019
Basic, Dominant Flex, KV-6
K150134 · Medela AG · Apr 2015
MEDELA DOMINANT 50 LIPO, MODEL 600-5706
K063336 · Medela AG · Feb 2007
MACROPORE PURICEL LIPOPLASTY SYSTEM
K042261 · Macropore Biosurgery, Inc. · Sep 2004
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
K041058 · Misonix, Inc. · May 2004