Cleared Traditional

ERCHONIA EML LASER

K041139 · Erchonia Medical, Inc. · Physical Medicine

Sep 2004

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K041139 is an FDA 510(k) clearance for the ERCHONIA EML LASER, a Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (Class II — Special Controls, product code NHN), submitted by Erchonia Medical, Inc. (Littleton, US). The FDA issued a Cleared decision on September 30, 2004, 153 days after receiving the submission on April 30, 2004. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K041139 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2004
Decision Date	September 30, 2004
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	NHN — Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5500
Definition	A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. This Device Emits Energy In The Infrared Or Other Wavelengths, Provides Non-heating And Non-thermal Effect, And Is Indicated For Adjunctive Use In Pain Therapy Or Related Indication. It Does Not Provide Therapeutic Topical Heating. The Classification Regulation For Infrared Lamps Describes A Device That Emits Energy In The Infrared Wavelength To Provide Topical Heating And That Is Not Limited To Adjunctive Use.