Cleared Traditional

Erchonia Violet ZERONA? Z6 OTC

K231474 · Erchonia Corporation · General & Plastic Surgery

Jul 2023

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K231474 is an FDA 510(k) clearance for the Erchonia Violet ZERONA? Z6 OTC, a Fat Reducing Low Level Laser (Class II — Special Controls, product code OLI), submitted by Erchonia Corporation (Melbourne, US). The FDA issued a Cleared decision on July 21, 2023, 60 days after receiving the submission on May 22, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number	K231474 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OLI — Fat Reducing Low Level Laser
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5400
Definition	Non-invasive Reduction In Fat Layer For Body Contouring