Clareon and Solarus Pulsed Light Devices and Accessories

K043319 is the FDA 510(k) clearance record for CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES, a class II device, cleared for Novalis Medical, LLC on 2004-12-17 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 one 510(k) clearance for Novalis Medical, LLC. As of 2026-09-10, FDA records show no recalls naming K043319.