The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses whichare guided through the aperture in the treatment objective .The optical system focuses the laser beam into the corneal tissue.The VisuMax femtosecond laser is indicated for use in ophthalmic surgery for the creation of corneal incisions in patients undergoing the following treatments:- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty- In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting- Surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.Additionally under class III: The VisuMax Femtosecond Laser is indicated for use in small incisionlenticule extraction (SMILE) for the reduction or elimination ofmyopia with or without astigmatism• for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters,• for cylinder from -0.75 diopters through -3.00 diopters,• when refraction spherical equivalent is no greater in magnitude than 10.00 diopters,in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for ocular resections and incisions (cataract incisions, arcuate corneal/scleral cuts/tunnels, anterior capsulotomy, phacofragmentations, corneal flaps, lamellar/perforating keratoplasty). The system includes a beam delivery device, imaging device, computer, software and controls; it cuts by micro-photodisruption of tissue created by focused ultra-short [femtosecond (FS)] pulses; it does not include fundus imaging technology and the therapeutic laser is not frequency-doubled.