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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 K231409
Device Name Erchonia FX-405
Applicant
Erchonia Corporation
650 Atlantis Rd.
Melbourne,  FL  32904
Applicant Contact Travis Sammons
Correspondent
Erchonia Corporation
650 Atlantis Rd.
Melbourne,  FL  32904
Correspondent Contact Travis Sammons
Regulation Number890.5500
Classification Product Code
NHN  
Date Received05/15/2023
Decision Date 08/11/2023
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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