Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo Lp1rg-S, Lp1rg-D

K052777 is the FDA 510(k) clearance record for LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D, a class II device, cleared for Ellex Medical Pty, Ltd. on 2006-03-16 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 13 510(k) clearances for Ellex Medical Pty, Ltd., from 1997-10-03 to 2022-11-02. As of 2026-09-10, FDA records show 2 recalls naming K052777.