Cleared Traditional

ZERONA

K133718 · Erchonia Corporation · General & Plastic Surgery
May 2014
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K133718 is an FDA 510(k) clearance for the ZERONA, a Fat Reducing Low Level Laser (Class II — Special Controls, product code OLI), submitted by Erchonia Corporation (Littleton, US). The FDA issued a Cleared decision on May 12, 2014, 159 days after receiving the submission on December 4, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number K133718 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2013
Decision Date May 12, 2014
Days to Decision 159 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

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