Elios Diode Ophthalmic Laser

K921320 is the FDA 510(k) clearance record for ELIOS DIODE OPHTHALMIC LASER, a class II device, cleared for Marco Ophthalmic, Inc. on 1992-07-02 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 15 510(k) clearances for Marco Ophthalmic, Inc., from 1992-07-02 to 1994-07-27. As of 2026-09-10, FDA records show no recalls naming K921320.