Cleared Traditional

K120257 - MLS, ZERONA-AD

K120257 is an FDA 510(k) clearance for MLS, manufactured by Erchonia Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OLI cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K120257 · Erchonia Medical, Inc. · General & Plastic Surgery device
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May 2012
Decision
108d
Days
Class 2
Risk

K120257 is an FDA 510(k) clearance for the MLS, ZERONA-AD. 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, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on May 14, 2012 after a review of 108 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K120257

510(k) Number K120257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2012
Decision Date May 14, 2012
Days to Decision 108 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 115d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01376037 Completed Interventional Industry-sponsored

Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference

An Evaluation of the Effectiveness of the Erchonia ML Scanner (MLS) as a Non-invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of the Upper Arms Clinical Study

62
Patients (actual)
Treatment
Purpose
Triple
Masking
Condition studied Body Contouring
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Mark S Nestor, M.D.,Ph.D.
Sponsor Erchonia Corporation (industry)
Started 2011-03-01 → Primary completion 2012-01-01
Primary outcome
Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint
View full study on ClinicalTrials.gov

Regulatory Peers - OLI Fat Reducing Low Level Laser

All 32
Devices cleared under the same product code (OLI) and FDA review panel - the closest regulatory comparables to K120257.
ZERONA 2.0 LASER
K123237 · Erchonia Corporation · Jan 2013
ETCHONIA ZERONA ARMS
K121690 · Erchonia Corporation · Aug 2012
ERCHONIA ZERONA
K121695 · Erchonia Corporation · Aug 2012
I-LIPO SYSTEM
K111501 · Chromogenex Technologies Limited · Mar 2012
ERCHONIA ML SCANNER (MLS)
DEN090008 · Erchonia Medical · Aug 2010