China Approves Zeiss Visumax 800 with SMILE Pro

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

Enhanced Workflow and Precision in Refractive Surgery

The Visumax 800 integrates advanced surgical tool and software enhancements, designed to improve safety, efficiency, and surgical outcomes. Key features include:

• CentraLign – A computer-controlled aid for easy centration of the treatment.

• OcuLign – A cyclotorsion adjustment tool for enhanced precision.

• VISULYZE – A data-driven nomogram system for collecting and analyzing patient data.

According to Zeiss, the Visumax 800 creates the lenticule in less than 10 seconds, utilizing a faster pulse repetition rate of 1MHz. This reduces procedure time, minimizing patient stress and improving efficiency for myopia and astigmatism correction.

Industry Perspectives on NMPA Approval

Maximilian Foerst, Head of Zeiss Greater China, emphasized the growing demand for laser vision 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. 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, Head of the Ophthalmology Strategic Business Unit at Zeiss Medical Technology, highlighted the competitive advantage this approval brings to Zeiss:

“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.”

Zeiss’ Global Expansion in Laser Vision Correction

In January 2025, the U.S. FDA approved Zeiss’ MEL 90 excimer laser for all three major indications:

• Myopia

• Hyperopia

• Mixed astigmatism

The MEL 90 integrates seamlessly into Zeiss’ Corneal Refractive Workflow, complementing the Visumax 800 and SMILE pro software to optimize surgical outcomes. Currently, the MEL 90 laser is only available in the United States.

Advancing Ophthalmic Technology in China

With the approval of the Visumax 800 with SMILE pro software, Zeiss reinforces its commitment to innovation in refractive surgery. This next-generation system will enable ophthalmologists across China to enhance surgical precision, improve patient outcomes, and streamline refractive procedures for myopia and astigmatism correction.