Cleared Traditional

K130922 - ERCHONIA VERJU LASER SYSTEM WITH MASSAGER

K130922 is an FDA 510(k) clearance for ERCHONIA VERJU LASER SYSTEM WITH MASSAGER, manufactured by Erchonia Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OLI cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K130922 · Erchonia Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
44d
Days
Class 2
Risk

K130922 is an FDA 510(k) clearance for the ERCHONIA VERJU LASER SYSTEM WITH MASSAGER. Classified as Fat Reducing Low Level Laser within the OLI classification (a category for non-invasive low-level laser body contouring systems), Class II - Special Controls.

Submitted by Erchonia Medical, Inc. (Littleton, US). The FDA issued a Cleared decision on May 17, 2013 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Erchonia Medical, Inc. devices

FDA 510(k) Submission Details - K130922

510(k) Number K130922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLI Device Classification - Class 2, Special Controls

Product Code OLI Fat Reducing Low Level Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5400
Definition Non-invasive Reduction In Fat Layer For Body Contouring
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OLI Fat Reducing Low Level Laser

All 23
Devices cleared under the same product code (OLI) and FDA review panel - the closest regulatory comparables to K130922.
Erchonia Zerona Z6 OTC
K143007 · Erchonia Corporation · Jan 2015
ERCHONIA SHL
K142042 · Erchonia Corporation · Oct 2014
ZERONA
K133718 · Erchonia Corporation · May 2014
ZERONA 2.0 LASER
K123237 · Erchonia Corporation · Jan 2013
ETCHONIA ZERONA ARMS
K121690 · Erchonia Corporation · Aug 2012
ERCHONIA ZERONA
K121695 · Erchonia Corporation · Aug 2012