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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 K150446
Device Name Erchonia Zerona 6 headed scanner EZ6
Applicant
ERCHONIA CORPORATION
2021 COMMERCE DRIVE
MCKINNEY,  TX  75069
Applicant Contact Steve Shanks
Correspondent
REGULATORY INSIGHT, INC.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.5400
Classification Product Code
OLI  
Date Received02/20/2015
Decision Date 05/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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