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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 K080530
Device Name MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
Applicant
CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE,  CA  94005
Applicant Contact KATHY MAYNOR
Correspondent
CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE,  CA  94005
Correspondent Contact KATHY MAYNOR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/26/2008
Decision Date 08/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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