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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 K170936
Device Name Cutera enlighten III Laser System
Applicant
Cutera, Inc.
3240 Bayshore Blvd.
Brisbane,  CA  94005
Applicant Contact Bradley Renton
Correspondent
Cutera, Inc.
3240 Bayshore Blvd.
Brisbane,  CA  94005
Correspondent Contact Bradley Renton
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/30/2017
Decision Date 04/25/2017
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
Predetermined Change
Control Plan Authorized		 No
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