Model 2100 Nd:yag Surgical Laser Neurosurgical Ind

K861044 is the FDA 510(k) clearance record for MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND, a class II device, cleared for Sharplan Industries, Inc. on 1986-10-28 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 4 510(k) clearances for Sharplan Industries, Inc., from 1986-04-23 to 1986-10-28. As of 2026-09-10, FDA records show no recalls naming K861044.