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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
Models M001-16F, M002-6A/2, M021-5AF/1, M021-5AF/2
Device Name LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
Original Applicant
FOTONA D.D.
stegne 7,
ljubljana,  SI 1210
Original 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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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