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VisiJet seeks U.S. approval of Epi-Tome

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IRVINE, Calif. — The distributor of a German-made epikeratome will seek U.S. regulatory approval of the device, the company announced this week.

VisiJet submitted a 510(k) application to the Food and Drug Administration for the Epi-Tome, a “next-generation, ophthalmic surgical tool designed for cutting and separating corneal tissue,” according to a press release from the company. VisiJet recently acquired worldwide distribution rights for the device from Gebauer Medizintechnik, of Neuhausen, Germany, the press release said.

The Epi-Tome is already approved for marketing in the European Union and is sold both there and in Korea, according to the press release.

The VisiJet press release said that the epi-LASIK procedure, in which the Epi-Tome is used, “solves many of the procedural problems associated with refractive corneal surgery using a lamellar flap (LASIK) as it better maintains the original structure of the cornea and eliminates the need for epithelial tissue removal through the use of alcohol.”