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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 K132185
Device Name FAMILY OF COOLGLIDE AESTHETIC LASERS
Applicant
CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE,  CA  94005
Applicant Contact SANDRA HANSEN
Correspondent
CUTERA, INC.
3240 BAYSHORE BLVD
BRISBANE,  CA  94005
Correspondent Contact SANDRA HANSEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/15/2013
Decision Date 12/06/2013
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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