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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K180709
Device Name truSculpt RF Device; truSculpt; truSculpt 3D
Applicant
Cutera, Inc.
3240 Bayshore Blvd.
Brisbane,  CA  94005
Applicant Contact Brad Renton
Correspondent
Cutera, Inc.
3240 Bayshore Blvd.
Brisbane,  CA  94005
Correspondent Contact Raymond Lee
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
GEI  
Date Received03/19/2018
Decision Date 06/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03428243
NCT03433417
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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