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Medical Equipment Manufacturing icon Eye Surgery Equipment Maker Business Plan

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Regulatory Issues

Since the “FDA does not approve procedures, only the equipment used in them” (“Eye centers set their sights on LASIK surgery growth,” Houston Business Journal, July 16, 1999)  and the components of the procedure have already been approved for FDA use, NovOculi’s products will be ready for the market as soon as medical research shows favorable results. The FDA has already approved the use of the 440 nm laser in the medical arena for dermatologic uses, and NovOculi will not need to obtain approval to use this device in the sculpting of the cornea. Similarly, iontophoretic devices, polymeric contact lenses and the targeting dye, tartrazine, have been approved by the FDA for human use and will require no additional approval at this juncture.

An example of such expedited market entrance can be seen with the laser vision correction procedure LASIK. Prior to its approval by the FDA in Winter of 1999, LASIK had been performed on 900,000 patients due to the fact that the laser used for LASIK, the excimer laser, had already been approved for medical use in PRK. (“Bye-Bye Glasses,” EyeCare Business Online, September 2000)  We hope to similarly expedite market entrance.