FDA Approves ZEISS' VISUMAX® 800 with SMILE® Pro Software for Nearsightedness Surgery

The FDA has approved the VISUMAX® 800 equipped with SMILE® pro software from ZEISS. This state-of-the-art femtosecond laser technology is designed for the surgical treatment of nearsightedness, with or without astigmatism.

The VISUMAX® 800 enters the U.S. market at a time when over 8 million eyes worldwide have already undergone treatment using SMILE, underscoring the technology's widespread global momentum, particularly in Asia and Europe.

Andrew Chang, Head of Global Sales for ZEISS Medical Technology, emphasized the positive impact of SMILE on patients' lives, stating, "The increasing global adoption of SMILE from ZEISS represents the positive impact the small incision lenticule extraction procedure continues to have on the quality of life for patients. With the availability of the ZEISS SMILE pro software module in the U.S. market, surgeons can now offer the latest refractive technology to help expand their business and provide excellent outcomes for patients.”

With the introduction of the ZEISS SMILE pro software module in the U.S. market, surgeons can now provide the latest refractive technology to expand their practices and deliver excellent outcomes for patients.

Euan S. Thomson, PhD, President of Ophthalmology Strategic Business Unit and Head of the Digital Business Unit for ZEISS Medical Technology, highlighted ZEISS's commitment to innovation in the U.S. market, stating, "ZEISS continues to set itself apart in the US market with the availability of the VISUMAX 800 with SMILE pro software from ZEISS, providing the latest digital technology from the company’s legacy of innovation to meet the evolving needs of refractive surgeons."

The VISUMAX® 800 with SMILE® pro software offers several advantages, including faster treatment times, with the creation of the lenticule taking less than 10 seconds due to a rapid laser pulse repetition rate of 2 MHz. This not only enhances efficiency but also reduces stress for both surgeons and patients.

The femtosecond laser system provides greater flexibility for surgeons and patients, boasting a smaller footprint and compatibility with various patient beds. It seamlessly adapts to the clinical environment, delivering cutting-edge technology without compromising on performance.

Surgeons in the United States can now benefit from workflow enhancements provided by the VISUMAX® 800 with SMILE® pro software, such as the CentraLign® centration aid for easy centration, the OcuLign® cyclotorsion adjustment to counter cyclotorsion, and VISULYZE user nomograms for data collection and analysis, offering enhanced control during surgeries.

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