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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 K123014
FOIA Releasable 510(k) K123014
Device Name LITECURE THERAPY SYSTEM MODEL LTS-1500
Applicant
Litecure, LLC
250 Corporate Blvd.
Suite B
Newark,  DE  19702
Applicant Contact LIANG LU
Correspondent
Litecure, LLC
250 Corporate Blvd.
Suite B
Newark,  DE  19702
Correspondent Contact LIANG LU
Regulation Number878.4810
Classification Product Code
PDZ  
Subsequent Product Code
ILY  
Date Received09/27/2012
Decision Date 03/29/2013
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
Predetermined Change
Control Plan Authorized		 No
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