Not Cleared Post-NSE

DEN090008 - ERCHONIA ML SCANNER (MLS)

DEN090008 is the FDA 510(k) submission for ERCHONIA ML SCANNER (MLS) by Erchonia Medical. It is a Class 2 General & Plastic Surgery device (product code OLI) cleared through the Post-NSE 510(k) pathway after a 596-day FDA review.

DEN090008 · Erchonia Medical · General & Plastic Surgery device
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Aug 2010
Decision
596d
Days
Class 2
Risk

DEN090008 is an FDA 510(k) submission (not cleared) for the ERCHONIA ML SCANNER (MLS). 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 Erchonia Medical (Greenwood Village, US). The FDA issued a Not Cleared (DENG) decision on August 24, 2010 after a review of 596 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 596 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN090008 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 05, 2009
Decision Date August 24, 2010
Days to Decision 596 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
481d slower than avg
Panel avg: 115d · This submission: 596d
Pathway characteristics

Device Classification

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.