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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 K180197
Device Name Erchonia FX-635
Applicant
Erchonia Corporation
650 Atlantis Rd.
Melbourne,  FL  32904
Applicant Contact Steven Shanks
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number890.5500
Classification Product Code
NHN  
Date Received01/24/2018
Decision Date 05/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Clinical Trials NCT02538523
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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