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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 K233803
Device Name UltraClear Laser System (N/A)
Applicant
Acclaro Corporation
333 George Washington Hwy.
Smithfield,  RI  02865
Applicant Contact Shlomo Assa
Correspondent
Acclaro Corporation
333 George Washington Hwy.
Smithfield,  RI  02865
Correspondent Contact Shlomo Assa
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received11/29/2023
Decision Date 05/08/2024
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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