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FDA Approves Zeiss’ ReLEx SMILE

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Zeiss’ medical technology segment has announced FDA premarket approval (PMA) for its ReLEx SMILE system, expanding myopia treatment to patients with astigmatism. ReLEx SMILE utilizes the high-precision femtosecond laser VisuMax to create a lenticule inside the cornea and an access incision in a single treatment step. Incisions are made through microscopic photodisruptions of tissue created by ultrashort pulses. The PMA also provides for a small entry incision to be made, allowing the SMILE procedure to be potentially less disruptive to the corneal surface tissue. The VisuMax...Read full article

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