Del Sol Blue Light Therapy System

K061470 is the FDA 510(k) clearance record for DEL SOL BLUE LIGHT THERAPY SYSTEM, a class II device, cleared for Edge Systems Corporation on 2006-07-20 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 3 510(k) clearances for Edge Systems Corporation, from 1999-05-04 to 2008-05-23. As of 2026-09-10, FDA records show no recalls naming K061470.