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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K041139
Device Name ERCHONIA EML LASER
Applicant
Erchonia Medical, Inc.
13 Red Fox Ln.
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Erchonia Medical, Inc.
13 Red Fox Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number890.5500
Classification Product Code
NHN  
Date Received04/30/2004
Decision Date 09/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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