Cleared Traditional

ETCHONIA ZERONA ARMS

K121690 · Erchonia Corporation · General & Plastic Surgery

Aug 2012

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K121690 is an FDA 510(k) clearance for the ETCHONIA ZERONA ARMS, 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 August 23, 2012, 77 days after receiving the submission on June 7, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number	K121690 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2012
Decision Date	August 23, 2012
Days to Decision	77 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