Cleared Traditional

K101413 - EUROMI EVA SP6

K101413 is an FDA 510(k) clearance for EUROMI EVA SP6, manufactured by Euromi S.A. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K101413 · Euromi S.A · General & Plastic Surgery device
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Dec 2010
Decision
210d
Days
Class 2
Risk

K101413 is an FDA 510(k) clearance for the EUROMI EVA SP6. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Euromi S.A (Shelton, US). The FDA issued a Cleared decision on December 16, 2010 after a review of 210 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 Euromi S.A devices

FDA 510(k) Submission Details - K101413

510(k) Number K101413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2010
Decision Date December 16, 2010
Days to Decision 210 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
95d slower than avg
Panel avg: 115d · This submission: 210d
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 28
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K101413.
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