IntraLase FS30 granted U.S. approval for penetrating and lamellar corneal resections
LISBON, Portugal — IntraLase announced U.S. Food and Drug Administration clearance for its femtosecond laser in the creation of corneal resections performed in lamellar keratoplasty and penetrating keratoplasty procedures. According to the company announcement here, this is the first and only laser to receive 510(k) clearance in the U.S.
With the new clearance, the IntraLase FS30 laser can be used to create deep corneal incisions and the full-thickness resections needed for penetrating keratoplasty.
“In our initial clinical work, we found that the laser has the ability to create shaped, full thickness corneal transplants that are much stronger than traditional penetrating keratoplasty transplants with less induction of astigmatism,” said Roger F. Steinert, MD, in a company press release. “In addition, transplants created with the laser may require less suturing and faster visual rehabilitation.”
The IntraLase was first introduced in the United States in 2001 as the first laser to create corneal flaps, the company said.