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..

总部位于德国耶拿的卡尔蔡司医疗技术公司宣布，其搭载SMILE pro软件的Visumax 800飞秒激光系统已获得中国国家药品监督管理局（NMPA）的批准。这一监管里程碑将扩大Visumax 800在亚洲地区进行小切口透镜提取（SMILE）手术的应用范围。

Enhanced Workflow and Precision in Refractive Surgery

提高屈光手术的工作流程和精确度

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

Visumax 800 集成了先进的手术工具和软件增强功能，旨在提高安全性、效率和手术效果。主要特点包括：

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

• CentraLign – 一种计算机控制的辅助工具，用于轻松实现治疗的中心定位。

• OcuLign – A cyclotorsion adjustment tool for enhanced precision.

• OcuLign – 一种用于提高精度的旋转型调整工具。

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

• VISULYZE – 一种数据驱动的列线图系统，用于收集和分析患者数据。

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.

根据蔡司的说法，Visumax 800 在不到 10 秒的时间内创建透镜，利用 1MHz 的更快脉冲重复率。这缩短了手术时间，减轻了患者的紧张情绪，并提高了近视和散光矫正的效率。

Industry Perspectives on NMPA Approval

行业对NMPA批准的看法

Maximilian Foerst, Head of Zeiss Greater China, emphasized the growing demand for laser vision correction in the region:

蔡司大中华区负责人福斯特强调，该地区对激光视力矫正的需求不断增长：

“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.”.

“随着中国对激光视力矫正的兴趣日益浓厚，市场需要创新技术以提升手术效果、安全性和效率，从而造福外科医生及其患者。蔡司VISUMAX 800配备SMILE pro软件的推出，进一步彰显了我们对眼科医生的支持，并有助于巩固激光视力矫正在中国的未来。”

Magnus Reibenspiess, Head of the Ophthalmology Strategic Business Unit at Zeiss Medical Technology, highlighted the competitive advantage this approval brings to Zeiss:

蔡司医疗技术公司眼科战略业务部负责人Magnus Reibenspiess强调了这一批准为蔡司带来的竞争优势：

“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.”

“这种下一代飞秒激光系统创造数据驱动的洞察力，帮助外科医生更好地管理患者的治疗路径，同时支持每位外科医生独特的实践需求，以提高工作流程效率和性能。”

Zeiss’ Global Expansion in Laser Vision Correction

蔡司在全球激光视力矫正领域的扩张

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

2025年1月，美国食品药品监督管理局（FDA）批准了蔡司的MEL 90准分子激光用于所有三大主要适应症：

• Myopia

• 近视

• Hyperopia

• 远视

• Mixed astigmatism

混合性散光

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.

MEL 90 无缝集成到蔡司的角膜屈光手术工作流程中，与 Visumax 800 和 SMILE pro 软件相辅相成，优化手术效果。目前，MEL 90 激光仅在美国可用。

Advancing Ophthalmic Technology in China

推进中国眼科技术的发展

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..

随着Visumax 800及其SMILE pro软件的获批，蔡司进一步巩固了其在屈光手术领域创新的承诺。这一下一代系统将使中国各地的眼科医生能够提高手术精度、改善患者效果，并简化近视和散光矫正的屈光手术流程。