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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 K120938
Device Name THE PL-1064 LASER SYSTEM
Original Applicant
189 winding oaks lane
oviedo,  FL  32765
Original Contact timothy j shea
Regulation Number878.4810
Classification Product Code
Subsequent Product Code
Date Received04/27/2012
Decision Date 09/24/2012
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