FDA approves the VISUMAX 800 with SMILE pro software for surgically treating nearsightedness

(Image Credit: AdobeStock/gustavofrazao)

Zeiss Medical Technology announced the US Food and Drug Administration (FDA) has approved the VISUMAX 800 with SMILE pro software surgically treating nearsightedness, with or without astigmatism.

The VISUMAX 800 is the latest generation of Zeiss femtosecond lasers, and offers a reduced laser time when compared to its predecessors.¹

According to press release from Zeiss,¹ the VISUMAX 800 with SMILE pro software enables faster treatment by “creating the lenticule in less than 10 seconds thanks to a faster laser pulse repetition rate of 2 MHz,” while “a shorter suction time can increase peace of mind and reduce stress for you and your patients.”

With the VISUMAX 800 with SMILE pro software surgeons can “utilize a number of workflow enhancements including the CentraLign centration aid, a computer-controlled function for easy centration; the OcuLign cyclotorsion adjustment to help counter cyclotorsion that may occur; and VISULYZE user nomograms to help surgeons collect and analyze patient data, while also providing detailed nomograms and enabling more control during every surgery.”¹

VISUMAX 800 with SMILE pro software from Zeiss. (Image courtesy Zeiss)

“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,” said Andrew Chang, Head of Global Sales for Zeiss Medical Technology. “With the availability of the Zeiss SMILE pro software module in the US market, surgeons can now offer the latest refractive technology to help expand their business and provide 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, discussed the approval in the press release from the company.

“As part of the Zeiss Medical Ecosystem, this next-generation femtosecond laser system creates data-driven insights to help surgeons manage better treatment paths for patients while supporting each surgeon’s unique practice requirements for greater workflow efficiency and performance,” said Thomson.

References:

1. U.S. FDA Approves the VISUMAX 800 with SMILE pro software from ZEISS. Press release; January 11, 2024. Accessed January 11, 2024. https://www.zeiss.com/meditec-ag/en/media-news/press-releases/2024/fda-approves-visumax-800-with-smile-pro.html?utm_source=ln-organic&utm_medium=image-post&utm_campaign=fda-visumax-us&utm_term=press-release&utm_content=post-1