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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 K211186
Device Name Erchonia XLR8
Applicant
Erchonia Corporation
650 Atlantis Road
Melbourne,  FL  32904
Applicant Contact Steven Shanks
Correspondent
Erchonia Corporation
650 Atlantis Road
Melbourne,  FL  32904
Correspondent Contact Travis Sammons
Regulation Number890.5500
Classification Product Code
NHN  
Date Received04/20/2021
Decision Date 10/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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