Fraxel® FTX Laser System

K242142 is the FDA 510(k) clearance record for Fraxel® FTX Laser System, a class II device, cleared for Solta Medical on 2024-08-21 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 37 510(k) clearances for Solta Medical, from 1999-08-12 to 2024-08-21. As of 2026-09-10, FDA records show no recalls naming K242142.