Improvements to the Mehl Ruby Laser

K971814 is the FDA 510(k) clearance record for IMPROVEMENTS TO THE MEHL RUBY LASER, a class II device, cleared for Mehl/Biophile Intl., Inc. on 1997-08-01 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 2 510(k) clearances for Mehl/Biophile Intl., Inc., from 1997-08-01 to 1998-06-29. As of 2026-09-10, FDA records show no recalls naming K971814.