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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
510(k) Number K153164
Device Name LunulaLaser
Applicant
ERCHONIA MEDICAL, INC.
2021 COMMERCE DR.
MCKINNEY,  TX  75069
Applicant Contact STEVE SHANKS
Correspondent
REGULATORY INSIGHT, INC.
33 GOLDEN EAGLE LANE
LITTLETON,  CO  80127
Correspondent Contact KEVIN WALLS
Regulation Number878.4810
Classification Product Code
PDZ  
Date Received11/02/2015
Decision Date 06/03/2016
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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