Irvine, CA-The FDA will let VisiJet Inc. sell its surgical device for separating corneal tissue in the United States, according to the company.
VisiJet, which owns worldwide distribution rights from Gebauer Medizintechnik GmbH of Neuhausen, Germany, describes the EpiLift System as a "next-generation" device for improving LASIK.
The company said the system provides "virtually instant" visual results of LASIK with the long-term outcomes of PRK. It is recommended for the correction of myopia, hyperopia, and astigmatism.
Earlier this year, VisiJet received the CE Mark and began to ship the EpiLift and LasiTome systems to 14 new markets. The new markets, which were announced Sept. 15, include Hong Kong, Korea, Malaysia, Germany, Russia, Romania, Cyprus, Italy, Spain, Jordan, the Benelux countries, Greece, Israel, and the United Kingdom.