FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm

K221623 is the FDA 510(k) clearance record for FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm, a class II device, cleared for Gme German Medical Engineering GmbH on 2023-03-10 under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 6 510(k) clearances for Gme German Medical Engineering GmbH, from 2014-07-15 to 2023-03-10. As of 2026-09-10, FDA records show no recalls naming K221623.