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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 K153671
Device Name Family of CoolGlide Aesthetic Lasers
Applicant
CUTERA, INC.
3240 BAYSHORE BLVD.
BRISBANE,  CA  94005
Applicant Contact Julia Brown
Correspondent
CUTERA, INC.
3240 BAYSHORE BLVD.
BRISBANE,  CA  94005
Correspondent Contact Julia Brown
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/21/2015
Decision Date 03/09/2016
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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