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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 K210951
Device Name Leonardo Mini Blue
Applicant
Ceramoptec GmbH
Siemensstrabe 44
Bonn,  DE D-53121
Applicant Contact Roland Dreschau
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/30/2021
Decision Date 09/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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