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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K221407
Device Name truSculpt iD
Applicant
Cutera, Inc.
3240 Bayshore Blvd.
Brisbane,  CA  94005
Applicant Contact Amogh Kothare
Correspondent
Cutera, Inc.
3240 Bayshore Blvd.
Brisbane,  CA  94005
Correspondent Contact Amogh Kothare
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/16/2022
Decision Date 07/13/2022
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
Predetermined Change
Control Plan Authorized		 No
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