BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E

K241358 is the FDA 510(k) clearance record for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E, a class II device, cleared for Sun Pharmaceutical Industries, Inc. on 2024-06-13 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 Sun Pharmaceutical Industries, Inc. As of 2026-09-10, FDA records show no recalls naming K241358.