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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
Applicant
SHEAUMANN LASER, INC
189 WINDING OAKS LANE
OVIEDO,  FL  32765
Applicant Contact TIMOTHY J SHEA
Correspondent
SHEAUMANN LASER, INC
189 WINDING OAKS LANE
OVIEDO,  FL  32765
Correspondent Contact TIMOTHY J SHEA
Regulation Number878.4810
Classification Product Code
PDZ  
Subsequent Product Code
GEX  
Date Received03/22/2012
Decision Date 09/24/2012
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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