FDA 510(k) Applications Submitted by GME German Medical Engineering GmbH

FDA 510(k) Number Submission Date Device Name Applicant
K221623 06/06/2022 FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm GME German Medical Engineering GmbH
K180518 02/27/2018 GME LinScan Lite 808 Laser System GME German Medical Engineering GmbH
K192269 08/21/2019 TwinScan 808/755 Laser System GME German Medical Engineering GmbH
K203054 10/07/2020 FlexSys GME German Medical Engineering GmbH


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