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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 K121508
Device Name LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
Applicant
Fotona D.D.
Stegne 7
Ljubljana,  SI 1210
Applicant Contact STOJAN TOST
Correspondent
Fotona D.D.
Stegne 7
Ljubljana,  SI 1210
Correspondent Contact STOJAN TOST
Regulation Number878.4810
Classification Product Code
PDZ  
Subsequent Product Code
GEX  
Date Received05/21/2012
Decision Date 12/12/2012
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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