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DaVinci femtosecond laser granted U.S. regulatory approval

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PORT, Switzerland — A femtosecond laser that generates “shorter, smaller, lower-energy infrared laser pulses” for corneal tissue dissection has been granted regulatory approval by the Food and Drug Administration, the device’s marketer said in a press release.

Ziemer Ophthalmic Systems said its DaVinci femtosecond laser had received Europe’s CE Mark a few weeks earlier, according to the release.

The DaVinci laser operates at an “extremely high pulse rate in the MHz range,” exceeding that of other femtosecond lasers “100-fold,” the company said. Ziemer officials added that initial clinical validation trials are under way and initial shipments of systems “dedicated to creating corneal flaps for LASIK surgery” are expected in June.