Device typeFemtosecond ophthalmic solid-state laser system: 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.
FDA categoryFemtosecond Laser System For Refractive Correction, Keratome, Ac-Powered, Laser, Ophthalmic
Device ID04049471110159
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information