FDA approves WaveLight's wavefront-guided LASIK therapy

The FDA approved WaveLight’s wavefront-guided procedure, a LASIK treatment approach that combines the Allegro Analyzer with the 200-Hz Allegretto Wave excimer laser.

The LASIK procedure is indicated for the correction of up to –7 D of spherical equivalent myopia or myopia with astigmatism, with up to –7 D of spherical component and up to 3 D of astigmatic component at the spectacle plane. The procedure is recommended for patients 18 years or older and for patients with documentation of stable manifest refraction defined as 0.5 D of preoperative spherical equivalent shift over 1 year prior to surgery.

“We are pleased that in addition to receiving mixed astigmatism approval last May, the Allegretto Wave has been granted yet another important FDA approval,” said WaveLight CEO Max Reindl. “WaveLight’s philosophy is to provide physicians with the technology to achieve superior outcomes, whether they choose to perform wavefront-optimized or wavefront-guided treatments. WaveLight will not increase the procedure fee for wavefront-guided treatments with the 200-Hz Allegretto Wave.”