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VisiJet expects quick approval for corneal tissue tool
August 1, 2004
VisiJet Inc. has filed a 510K statement with the FDA for approval of the Epi-Tome, a next-generation ophthalmic surgical tool designed for cutting and separating corneal tissue.
VisiJet Inc. has filed a 510K statement with the FDA for approval of the Epi-Tome, a next-generation ophthalmic surgical tool designed for cutting and separating corneal tissue.
The company has secured worldwide distribution rights from Gebauer Medizintechnik GmbH of Neuhausen, Germany. The product has earned the CE mark and is being sold in Europe and Korea.
VisiJet expects an expedited FDA approval by fall.OT