Innovaquartz General Shape Laser Fiber

K994010 is the FDA 510(k) clearance record for INNOVAQUARTZ GENERAL SHAPE LASER FIBER, a class II device, cleared for Innovaquartz on 1999-12-17 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 6 510(k) clearances for Innovaquartz, from 1999-12-17 to 2024-05-03. As of 2026-09-10, FDA records show no recalls naming K994010.