Hakon, Hakon Smart

K231901 is the FDA 510(k) clearance record for Hakon, Hakon Smart, a class II device, cleared for Medical San Indústria DE Equipamentos Médicos Ltda. on 2023-09-28 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 2 510(k) clearances for Medical San Indústria DE Equipamentos Médicos Ltda., from 2023-09-28 to 2024-09-16. As of 2026-09-10, FDA records show no recalls naming K231901.