Gme (German Medical Engineering) GmbH - FDA 510(k) Cleared Devices
Recent clearances: FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm, FlexSys, TwinScan 808/755 Laser System
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gme (German Medical Engineering) GmbH General & Plastic Surgery ✕
6 devices
Cleared
Mar 10, 2023
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
General & Plastic Surgery
277d
Cleared
Mar 05, 2021
FlexSys
General & Plastic Surgery
149d
Cleared
Nov 19, 2019
TwinScan 808/755 Laser System
General & Plastic Surgery
90d
Cleared
Jul 23, 2018
GME LinScan Lite 808 Laser System
General & Plastic Surgery
146d
Cleared
Jul 31, 2015
GME ExSys 308
General & Plastic Surgery
130d
Cleared
Jul 15, 2014
LINSCAN 808, LINSCAN 980
General & Plastic Surgery
82d