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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 K113702
Device Name FOTONA XP ND: YAG LASER SYSTEM
Applicant
FOTONA D.D.
stegne 7,
ljubljana,  SI 1000
Applicant Contact stojan trost
Correspondent
FOTONA D.D.
stegne 7,
ljubljana,  SI 1000
Correspodent Contact stojan trost
Regulation Number878.4810
Classification Product Code
PDZ  
Subsequent Product Code
GEX  
Date Received12/16/2011
Decision Date 03/28/2012
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
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