Cleared Traditional

K123237 - ZERONA 2.0 LASER

K123237 is an FDA 510(k) clearance for ZERONA 2.0 LASER, manufactured by Erchonia Corporation. The device is a Class 2 General & Plastic Surgery device with product code OLI cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K123237 · Erchonia Corporation · General & Plastic Surgery device
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Jan 2013
Decision
101d
Days
Class 2
Risk

K123237 is an FDA 510(k) clearance for the ZERONA 2.0 LASER. 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 Corporation (Littleton, US). The FDA issued a Cleared decision on January 25, 2013 after a review of 101 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.

View all Erchonia Corporation devices

FDA 510(k) Submission Details - K123237

510(k) Number K123237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2012
Decision Date January 25, 2013
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
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
NCT01292538 Completed Interventional Industry-sponsored

Study of the Effectiveness of Green Diode Laser Light on Body Shaping

A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia Scanner Device (GLS) Green Diode on Body Contouring of the Waist, Hips and Thighs

67
Patients (actual)
2
Sites
Treatment
Purpose
Triple
Masking
Condition studied Body Contouring
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Gregory C Roche, MD, FACS
Sponsor Erchonia Corporation (industry)
Started 2011-02-01 → Primary completion 2012-06-01
Primary outcome
Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs
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 K123237.
ZERONA
K133718 · Erchonia Corporation · May 2014
STRAWBERRY, STRAWBERRY & CREAM
K130341 · Laser Lipo Limited · Sep 2013
ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
K130922 · Erchonia Medical, Inc. · May 2013
ETCHONIA ZERONA ARMS
K121690 · Erchonia Corporation · Aug 2012
ERCHONIA ZERONA
K121695 · Erchonia Corporation · Aug 2012
MLS, ZERONA-AD
K120257 · Erchonia Medical, Inc. · May 2012