Cleared Traditional

ERCHONIA VERJU LASER SYSTEM WITH MASSAGER

K130922 · Erchonia Medical, Inc. · General & Plastic Surgery
May 2013
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K130922 is an FDA 510(k) clearance for the ERCHONIA VERJU LASER SYSTEM WITH MASSAGER, a Fat Reducing Low Level Laser (Class II — Special Controls, product code OLI), submitted by Erchonia Medical, Inc. (Littleton, US). The FDA issued a Cleared decision on May 17, 2013, 44 days after receiving the submission on April 3, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number K130922 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2013
Decision Date May 17, 2013
Days to Decision 44 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