IntraLase FS30 laser gets 510K approval for penetrating, lamellar corneal resections

September 12, 2005

Lisbon, Portugal - IntraLase Corp., Irvine, CA, has received 510K clearance from the FDA for use of the IntraLase FS30 femtosecond laser in creating corneal resections performed in lamellar keratoplasty and penetrating keratoplasty (PK) procedures. The IntraLase FS30 laser is the first and only laser to receive clearance for use in PK, according to the manufacturer.

Lisbon, Portugal - IntraLase Corp., Irvine, CA, has received 510K clearance from the FDA for use of the IntraLase FS30 femtosecond laser in creating corneal resections performed in lamellar keratoplasty and penetrating keratoplasty (PK) procedures. The IntraLase FS30 laser is the first and only laser to receive clearance for use in PK, according to the manufacturer.

The company said surgeons can now use the power and precision of the laser to complete resections in a variety of corneal therapeutic applications. The new clearance allows use of the IntraLase FS30 laser to create deep corneal incisions and the full-thickness resections required for PK.

"This really opens up the door for additional uses of this extremely versatile device," said Roger Steinert, MD, of the University of California, Irvine, United States. "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 PK transplants with less induction of astigmatism. In addition, transplants created with the laser may require less suturing and faster visual rehabilitation."

IntraLase is developing commercially available software for these new applications as well as a new curved applanation lens to facilitate deep corneal dissections. The laser's current flat applanation lens provides the thin, planar flaps that have recently been shown to improve LASIK outcomes.

For more information, visit IntraLase at Booth #234.