Cleared Traditional

K231474 - Erchonia Violet ZERONA® Z6 OTC (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K231474 · Erchonia Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
60d
Days
Class 2
Risk

K231474 is an FDA 510(k) clearance for the Erchonia Violet 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 (Melbourne, US). The FDA issued a Cleared decision on July 21, 2023 after a review of 60 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

Submission Details

510(k) Number K231474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2023
Decision Date July 21, 2023
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 114d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT05674292 Completed Interventional Industry-sponsored

An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring

25
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Circumference Reduction
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Erchonia Corporation (industry)
Started 2022-07-11 → Primary completion 2023-03-28
Primary outcome
Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs
View full study on ClinicalTrials.gov

Regulatory Peers - OLI Fat Reducing Low Level Laser

All 31
Devices cleared under the same product code (OLI) and FDA review panel - the closest regulatory comparables to K231474.
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
K260129 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Apr 2026
Contour Light (CL-100)
K243854 · Contour Research, LLC · Feb 2026
Erchonia CLX (Model # CFL)
K252574 · Erchonia Corporation · Dec 2025
Led Light Phototherapy Bed (Pro 450/ GY-680A)
K252786 · Shenzhen Suyzeko Limited. · Dec 2025
Erchonia Zerona® VZ8
K243811 · Erchonia Corporation · Jan 2025
Erchonia Zerona Z-Bed
K220519 · Erchonia Corporation · Mar 2022