Opelaser Pro II and the Opelaser Lite II

K120932 is the FDA 510(k) clearance record for OPELASER PRO II AND THE OPELASER LITE II, a class II device, cleared for The Yoshida Dental Mfg. Co., Ltd. on 2012-12-07 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 9 510(k) clearances for The Yoshida Dental Mfg. Co., Ltd., from 1982-10-21 to 2019-01-31. As of 2026-09-10, FDA records show no recalls naming K120932.