Depilite El-8B Series Dermo Flash Systems

K052371 is the FDA 510(k) clearance record for DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS, a class II device, cleared for Hair International Systems USA, Inc. on 2006-05-04 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 Hair International Systems USA, Inc. As of 2026-09-10, FDA records show no recalls naming K052371.