China issues approval for Zeiss Visumax 800 with SMILE pro software

Image courtesy Carl Zeiss Meditec AG.

Carl Zeiss Meditec AG, based in Jena, Germany, announced its Visumax 800 femtosecond laser with SMILE pro software has received approval from the National Medical Products Administration (NMPA) in China. The NMPA approval will expand access to small incision lenticule extraction (SMILE) procedures conducted with the Visumax 800 across Asia.

In a press release, Zeiss outlined the workflow enhancements which are part of the surgical tool and software suite, including a computer-controlled aid for easy centration (CentraLign); cyclotorsion adjustment (OcuLign); and user nomograms for collecting and analysing patient data (VISULYZE).¹ According to the company, the Visumax 800 creates the lenticule “in less than 10 seconds thanks to a faster pulse repetition rate of 1MHz.” The shortened procedure time reduces stress for patients and enables practitioners to provide an efficient experience for patients with myopia with or without astigmatism.

Maximilian Foerst, who is the head of Zeiss Greater China, commented on the approval and the broader landscape of laser correction in the region. “With the growing interest in laser vision correction in China, the market needs innovative technology that enhances surgical outcomes, safety and efficiency to benefit both surgeons and their patients,” he said. “The availability of the ZEISS VISUMAX 800 with SMILE pro software further extends our commitment to ophthalmologists and helps to solidify the future of laser vision correction across China.”

Magnus Reibenspiess, the head of the ophthalmology strategic business unit at Zeiss Medical Technology, also provided a statement, acknowledging that the approval sets Zeiss apart from other ophthalmic tech manufacturers in the Chinese market. “This next-generation femtosecond laser system creates data-driven insights to help surgeons better manage treatment paths for patients while supporting each surgeon’s unique practice requirements for greater workflow efficiency and performance,” he said.

In January of 2025, the US FDA granted its approval to the excimer laser MEL 90 from Zeiss for all three major indications: myopia, hyperopia and mixed astigmatism. The laser fully integrates into the Corneal Refractive Workflow from Zeiss as a complement to Visumax 800 and SMILE pro software to streamline surgical correction with positive outcomes. The MEL 90 laser is currently only available in the United States.²

References

1. ZEISS VISUMAX 800 with SMILE pro software receives approval in China. Carl Zeiss Meditec AG. Press release. Published February 26, 2025. Accessed February 26, 2025. https://www.zeiss.com/meditec-ag/en/media-news/press-releases/2025/zeiss-visumax-800-approval-china.html

2. Joy J. US FDA approves Zeiss MEL 90 excimer laser for myopia, hyperopia and mixed astigmatism. Ophthalmology Times Europe. Published January 14, 2025. Accessed February 26, 2025. https://europe.ophthalmologytimes.com/view/us-fda-approves-zeiss-mel-90-excimer-laser-for-myopia-hyperopia-and-mixed-astigmatism