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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fat Reducing Low Level Laser
510(k) Number K192544
Device Name Erchonia Emerald
Applicant
Erchonia Corporation
650 Atlantis Rd.
Melbourne,  FL  32904
Applicant Contact Steven Shanks
Correspondent
Erchonia Corporation
650 Atlantis Rd.
Melbourne,  FL  32904
Correspondent Contact Steven Shanks
Regulation Number878.5400
Classification Product Code
OLI  
Date Received09/16/2019
Decision Date 01/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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