Cleared Traditional

ERCHONIA SHL

K142042 · Erchonia Corporation · General & Plastic Surgery
Oct 2014
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K142042 is an FDA 510(k) clearance for the ERCHONIA SHL, 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 October 21, 2014, 85 days after receiving the submission on July 28, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number K142042 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2014
Decision Date October 21, 2014
Days to Decision 85 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