Evlt Kit and the D15plus and D30plus Diode Lasers

K041957 is the FDA 510(k) clearance record for EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS, a class II device, cleared for Diomed, Inc. on 2004-12-01 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 8 510(k) clearances for Diomed, Inc., from 1999-02-26 to 2007-01-25. As of 2026-09-10, FDA records show one recall naming K041957.