Flexus 2 CO2 Surgical Laser System

K850985 is the FDA 510(k) clearance record for FLEXUS 2 CO2 SURGICAL LASER SYSTEM, a class II device, cleared for Intl. Solarium Manufacturer, Inc. on 1985-03-25 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 Intl. Solarium Manufacturer, Inc., from 1985-03-25 to 1985-11-08. As of 2026-09-10, FDA records show no recalls naming K850985.