Cleared Traditional

K142042 - ERCHONIA SHL

K142042 is an FDA 510(k) clearance for ERCHONIA SHL, manufactured by Erchonia Corporation. The device is a Class 2 General & Plastic Surgery device with product code OLI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

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

K142042 is an FDA 510(k) clearance for the ERCHONIA SHL. 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 Corporation (Littleton, US). The FDA issued a Cleared decision on October 21, 2014 after a review of 85 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 Corporation devices

FDA 510(k) Submission Details - K142042

510(k) Number K142042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01821352 Completed Interventional Industry-sponsored

Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia Obesity Laser on the Reduction of Circumference of the Hips, Waist and Upper Abdomen for Individuals With a Body Mass Index (BMI) of 30 to 40 kg/m2

53
Patients (actual)
2
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Obesity
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Steven Shanks
Sponsor Erchonia Corporation (industry)
Started 2013-03-01 → Primary completion 2014-04-01
Primary outcome
Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements
View full study on ClinicalTrials.gov

Regulatory Peers - OLI Fat Reducing Low Level Laser

All 32
Devices cleared under the same product code (OLI) and FDA review panel - the closest regulatory comparables to K142042.
Erchonia Zerona 6 headed scanner EZ6
K150446 · Erchonia Corporation · May 2015
Lipofina Laser System
K143741 · Yolo Medical, Inc. · Apr 2015
Erchonia Zerona Z6 OTC
K143007 · Erchonia Corporation · Jan 2015
BTL-9000
K134040 · Btl Industries, Ltd. · Sep 2014
ZERONA
K133718 · Erchonia Corporation · May 2014
STRAWBERRY, STRAWBERRY & CREAM
K130341 · Laser Lipo Limited · Sep 2013