Cleared Traditional

Erchonia Zerona 6 headed scanner EZ6

K150446 · Erchonia Corporation · General & Plastic Surgery
May 2015
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K150446 is an FDA 510(k) clearance for the Erchonia Zerona 6 headed scanner EZ6, a Fat Reducing Low Level Laser (Class II — Special Controls, product code OLI), submitted by Erchonia Corporation (Mckinney, US). The FDA issued a Cleared decision on May 21, 2015, 90 days after receiving the submission on February 20, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number K150446 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2015
Decision Date May 21, 2015
Days to Decision 90 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