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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 K213461
Device Name AviClear Laser System
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 Number878.4810
Classification Product Code
GEX  
Date Received10/27/2021
Decision Date 03/24/2022
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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