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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 K050679
Device Name CUTERA SOLERA OPUS AESTHETIC PRODUCT
Original Applicant
CUTERA, INC.
3240 bayshore blvd.
brisbane,  CA  94005
Original Contact kathy maynor
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/16/2005
Decision Date 03/31/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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