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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K070138
Device Name CUTERA ER:YAG LASER HANDPIECE
Original Applicant
CUTERA, INC.
3240 bayshore blvd
brisbane,  CA  94005
Original Contact connie hoy
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/16/2007
Decision Date 03/27/2007
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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