Cleared Traditional

K143007 - Erchonia Zerona Z6 OTC

K143007 is an FDA 510(k) clearance for Erchonia Zerona Z6 OTC, 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 87-day FDA review.

K143007 · Erchonia Corporation · General & Plastic Surgery device
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Jan 2015
Decision
87d
Days
Class 2
Risk

K143007 is an FDA 510(k) clearance for the Erchonia Zerona Z6 OTC. 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 (Mckinney, US). The FDA issued a Cleared decision on January 15, 2015 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Erchonia Corporation devices

FDA 510(k) Submission Details - K143007

510(k) Number K143007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2014
Decision Date January 15, 2015
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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.

Regulatory Consultant

Regulatory Insight, Inc.
Kevin Walls

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02167867 Completed Interventional Industry-sponsored

Study of Over-The-Counter Use of Low Level Laser Light Therapy for Body Contouring of the Waist, Hips and Thighs

Evaluation of Efficacy, Usability and Labeling Comprehension for Over-the-Counter Use of the Erchonia Corporation ZERONA® Z6 for Body Contouring of the Waist, Hips and Thighs

44
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Circumference Reduction
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Joseph Zapolsky
Sponsor Erchonia Corporation (industry)
Started 2014-07-01 → Primary completion 2014-09-01
Primary outcome
Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments
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 K143007.
Photonica Professional
K160880 · Ward Photonics, LLC · Sep 2016
Erchonia Zerona 6 headed scanner EZ6
K150446 · Erchonia Corporation · May 2015
Lipofina Laser System
K143741 · Yolo Medical, Inc. · Apr 2015
ERCHONIA SHL
K142042 · Erchonia Corporation · Oct 2014
BTL-9000
K134040 · Btl Industries, Ltd. · Sep 2014
ZERONA
K133718 · Erchonia Corporation · May 2014