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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 K221623
FOIA Releasable 510(k) K221623
Device Name FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
Applicant
Gme German Medical Engineering GmbH
Dreikoenigstr. 6-8
Erlangen,  DE 91054
Applicant Contact Dietmar Fischer
Correspondent
Gme German Medical Engineering GmbH
Dreikoenigstr. 6-8
Erlangen,  DE 91054
Correspondent Contact Dietmar Fischer
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
FTC  
Date Received06/06/2022
Decision Date 03/10/2023
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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