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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 K113843
Device Name FREEDOM ND: YAG LASER SYSTEM
Applicant
Lutronic Corporation
6 Neshaminy Interplex,
Suite 207
Trevose,  PA  19053
Applicant Contact JHUNG WON VOJIR
Correspondent
Lutronic Corporation
6 Neshaminy Interplex,
Suite 207
Trevose,  PA  19053
Correspondent Contact JHUNG WON VOJIR
Regulation Number878.4810
Classification Product Code
PDZ  
Subsequent Product Code
GEX  
Date Received12/28/2011
Decision Date 09/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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