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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 K231474
Device Name Erchonia Violet ZERONA® Z6 OTC
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 Number878.5400
Classification Product Code
OLI  
Date Received05/22/2023
Decision Date 07/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT05674292
Reviewed by Third Party No
Combination Product No
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