Medilas H Rfid Laser Fiber

K121938 is the FDA 510(k) clearance record for MEDILAS H RFID LASER FIBER, a class II device, cleared for Dornier Medtech America, Inc. on 2012-08-01 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 46 510(k) clearances for Dornier Medtech America, Inc., from 1990-11-21 to 2025-01-31. As of 2026-09-10, FDA records show no recalls naming K121938.