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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 K220519
Device Name Erchonia Zerona Z-Bed
Applicant
Erchonia Corporation
650 Atlantis Road
Melbourne,  FL  32904
Applicant Contact Travis Sammons
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.5400
Classification Product Code
OLI  
Date Received02/23/2022
Decision Date 03/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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