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FDA clears Victus for corneal incisions
The Victus femtosecond laser platform has received 510(k) clearance from the U.S. Food and Drug Administration for the creation of corneal incisions, according to a press release from Bausch + Lomb.
The cuts or incisions can be created in the cornea of patients undergoing cataract surgery or other ophthalmic treatments that require corneal incisions. They can be made in a variety of diameters, depths, angles and planes.
The Victus was previously granted FDA clearance for arcuate incisions, for the creation of a corneal flap in patients undergoing LASIK or other treatments requiring initial lamellar resection of the cornea, and for anterior capsulotomy during cataract surgery.
In Europe, it has received a CE mark for capsulotomy, lens fragmentation, arcuate corneal incisions, corneal incisions, LASIK flap, penetrating keratoplasty and intrastromal channel incisions for intracorneal ring segments, the release said.