Carl Zeiss Meditec’s MEL 80 Excimer Laser has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the treatment of hyperopia.
The new indication complements the existing FDA approved applications of the surgical laser for myopia and astigmatism.
The MEL 80 Excimer Laser is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of > +0.5 D and < +3.0 D, with a maximum MRSE of +5.0 D, in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of < 0.5 D.
Carl Zeiss Meditec president and CEO Ludwin Monz said the MEL 80 combines premium optics with advanced excimer laser technology.
"Adding the hyperopia indication enables us to offer a complete range of treatment options to meet the demands of refractive surgeons and their patients," Monz said.