Accu-Beam Laser Block 301513Bg385/beam Splitters 301513Bg39

K963193 is the FDA 510(k) clearance record for ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39, a class II device, cleared for Transamerican Technologies Intl. on 1996-11-13 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 Transamerican Technologies Intl., from 1987-03-05 to 1997-08-20. As of 2026-09-10, FDA records show no recalls naming K963193.