Cleared Traditional

K111501 - I-LIPO SYSTEM

K111501 is an FDA 510(k) clearance for I-LIPO SYSTEM, manufactured by Chromogenex Technologies Limited. The device is a Class 2 General & Plastic Surgery device with product code OLI cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K111501 · Chromogenex Technologies Limited · General & Plastic Surgery device
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Mar 2012
Decision
297d
Days
Class 2
Risk

K111501 is an FDA 510(k) clearance for the I-LIPO SYSTEM. Classified as Fat Reducing Low Level Laser within the OLI classification (a category for non-invasive low-level laser body contouring systems), Class II - Special Controls.

Submitted by Chromogenex Technologies Limited (Llanelli, Carmarthenshire, GB). The FDA issued a Cleared decision on March 23, 2012 after a review of 297 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5400 - 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 Chromogenex Technologies Limited devices

FDA 510(k) Submission Details - K111501

510(k) Number K111501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2011
Decision Date March 23, 2012
Days to Decision 297 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
182d slower than avg
Panel avg: 115d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLI Device Classification - Class 2, Special Controls

Product Code OLI Fat Reducing Low Level Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5400
Definition Non-invasive Reduction In Fat Layer For 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.