Cleared Traditional

MLS, ZERONA-AD

K120257 · Erchonia Medical, Inc. · General & Plastic Surgery
May 2012
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K120257 is an FDA 510(k) clearance for the MLS, ZERONA-AD, a Fat Reducing Low Level Laser (Class II — Special Controls, product code OLI), submitted by Erchonia Medical, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on May 14, 2012, 108 days after receiving the submission on January 27, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number K120257 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2012
Decision Date May 14, 2012
Days to Decision 108 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