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ZEISS VISUMAX 800 with SMILE pro software receives approval in China

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ZEISS Medical Technology has received approval from China's National Medical Products Administration (NMPA) for its VISUMAX 800 with SMILE pro software, designed for treating nearsightedness with or without astigmatism. This latest femtosecond laser system enters the Chinese market after successful treatment of over 10 million eyes worldwide.

The system offers significant improvements including:

  • Faster treatment with lenticule creation in under 10 seconds using 2 MHz laser pulse rate
  • Enhanced workflow features including CentraLign centration aid and OcuLign cyclotorsion adjustment
  • VISULYZE user nomograms for data collection and analysis
  • Smaller footprint and compatibility with various patient beds

ZEISS Medical Technology ha ricevuto l'approvazione dalla National Medical Products Administration (NMPA) della Cina per il suo VISUMAX 800 con software SMILE pro, progettato per il trattamento della miopia con o senza astigmatismo. Questo ultimo sistema laser a femtosecondi entra nel mercato cinese dopo aver trattato con successo oltre 10 milioni di occhi in tutto il mondo.

Il sistema offre miglioramenti significativi che includono:

  • Trattamento più veloce con creazione di lenticoli in meno di 10 secondi utilizzando una frequenza di impulso laser di 2 MHz
  • Funzionalità di flusso di lavoro migliorate, inclusi l'aiuto alla centratura CentraLign e l'aggiustamento della ciclotorsione OcuLign
  • Nomogrammi utente VISULYZE per la raccolta e l'analisi dei dati
  • Ingombro ridotto e compatibilità con vari letti per pazienti

ZEISS Medical Technology ha recibido la aprobación de la Administración Nacional de Productos Médicos (NMPA) de China para su VISUMAX 800 con software SMILE pro, diseñado para tratar la miopía con o sin astigmatismo. Este último sistema láser de femtosegundos entra en el mercado chino tras el exitoso tratamiento de más de 10 millones de ojos en todo el mundo.

El sistema ofrece mejoras significativas que incluyen:

  • Tratamiento más rápido con creación de lentículos en menos de 10 segundos utilizando una frecuencia de pulso láser de 2 MHz
  • Características de flujo de trabajo mejoradas, incluyendo la ayuda de centrado CentraLign y el ajuste de ciclotorsión OcuLign
  • Nomogramas de usuario VISULYZE para la recopilación y análisis de datos
  • Menor huella y compatibilidad con varias camas para pacientes

ZEISS Medical Technology는 중국 국가의약품감독관리국(NMPA)으로부터 근시와 난시 치료를 위해 설계된 VISUMAX 800과 SMILE pro 소프트웨어에 대한 승인을 받았습니다. 이 최신 펨토초 레이저 시스템은 전 세계적으로 1천만 개 이상의 눈을 성공적으로 치료한 후 중국 시장에 진입합니다.

이 시스템은 다음과 같은 중요한 개선 사항을 제공합니다:

  • 2 MHz 레이저 펄스 속도를 사용하여 10초 이내에 렌티큘을 생성하는 더 빠른 치료
  • CentraLign 중심 조정 보조기구 및 OcuLign 회전 조정 기능을 포함한 향상된 작업 흐름 기능
  • 데이터 수집 및 분석을 위한 VISULYZE 사용자 노모그램
  • 작은 공간 차지 및 다양한 환자 침대와의 호환성

ZEISS Medical Technology a reçu l'approbation de l'Administration nationale des produits médicaux (NMPA) de Chine pour son VISUMAX 800 avec logiciel SMILE pro, conçu pour traiter la myopie avec ou sans astigmatisme. Ce dernier système laser à femtosecondes entre sur le marché chinois après avoir traité avec succès plus de 10 millions d'yeux dans le monde.

Le système offre des améliorations significatives, notamment :

  • Un traitement plus rapide avec création de lenticules en moins de 10 secondes grâce à un taux de pulsation laser de 2 MHz
  • Des fonctionnalités de flux de travail améliorées, y compris l'aide à la centration CentraLign et l'ajustement de la cyclotorsion OcuLign
  • Des nomogrammes d'utilisateur VISULYZE pour la collecte et l'analyse des données
  • Un encombrement réduit et une compatibilité avec divers lits pour patients

ZEISS Medical Technology hat von der Nationalen Medizinprodukteverwaltung Chinas (NMPA) die Genehmigung für ihr VISUMAX 800 mit SMILE pro Software erhalten, das zur Behandlung von Kurzsichtigkeit mit oder ohne Astigmatismus entwickelt wurde. Dieses neueste Femtosekunden-Lasersystem betritt den chinesischen Markt, nachdem weltweit über 10 Millionen Augen erfolgreich behandelt wurden.

Das System bietet bedeutende Verbesserungen, darunter:

  • Schnellere Behandlung mit der Erstellung von Lenticuli in weniger als 10 Sekunden bei einer Laserpulsrate von 2 MHz
  • Verbesserte Arbeitsablauffunktionen, einschließlich der CentraLign Zentrierhilfe und der OcuLign Zyklotorsionsanpassung
  • VISULYZE Benutzer-Nomogramme zur Datenerfassung und -analyse
  • Kompaktere Bauweise und Kompatibilität mit verschiedenen Patientenliegen

Positive
  • NMPA approval enables market access in China
  • Proven track record with 10M+ eyes treated globally
  • Enhanced treatment speed (sub-10 second procedure)
  • Advanced workflow features for improved surgical efficiency
Negative
  • None.

Updated ZEISS femtosecond laser provides refractive surgeons in China with faster treatment, greater flexibility, and significant workflow 

JENA, Germany and SHANGHAI, Feb. 26, 2025 /PRNewswire/ -- ZEISS Medical Technology announced today that the National Medical Products Administration (NMPA) in China has approved the VISUMAX® 800 with SMILE® pro software from ZEISS for surgically treating nearsightedness, with or without astigmatism. The latest generation of femtosecond lasers from ZEISS enters the China market at a time when more than 10 million eyes have been treated with ZEISS SMILE and SMILE pro worldwide, reflecting the technology's broad global momentum driven by strong adoption in Asia, Europe and the U.S.

"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," says Maximilian Foerst, Head of ZEISS Greater China.

"ZEISS further sets itself apart in the China market with the availability of the VISUMAX 800 with SMILE pro software from ZEISS, providing the latest digital technology to meet the evolving needs of refractive surgeons worldwide," said Magnus Reibenspiess, Head of Strategic Business Unit Ophthalmology at ZEISS Medical Technology. "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."

The VISUMAX® 800 with SMILE® pro software from ZEISS enables faster treatment, creating the lenticule in less than 10 seconds thanks to a faster laser pulse repetition rate of 2 MHz.* Additionally, the shorter procedure time can reduce stress for surgeons and their patients. The ZEISS femtosecond laser also provides greater flexibility for the surgeon and patient, with a smaller footprint and compatibility with a variety of patient beds, adapting to the clinical environment to provide cutting-edge technology without compromise.

With the availability of the VISUMAX® 800 with SMILE® pro software from ZEISS in China, 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.

With these workflow enhancements along with greater flexibility and faster treatment, the VISUMAX® 800 with SMILE® pro software from ZEISS offers substantial market opportunities for surgeons in China. For more information about the VISUMAX® 800 with SMILE® pro software from ZEISS, visit https://zeiss.com/visumax800  

* Data on file, myopia with optical zone 6.5 mm.

Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another. For country-specific product information, see the appropriate country website. Product specifications are subject to change in design and scope of delivery as a result of ongoing technical development. The statements of the healthcare professionals reflect only their personal opinions and experiences and do not necessarily reflect the opinion of any institution that they are affiliated with. The healthcare professionals alone are responsible for the content of their experience reported and any potential resulting infringements. Carl Zeiss Meditec AG and its affiliates to not have clinical evidence supporting the opinions and statements of the health care professionals nor accept any responsibility or liability of the healthcare professionals' content. The healthcare professionals have a contractual or other financial relationship with Carl Zeiss Meditec AG and its affiliates and have received financial support.

Contact for investors
Sebastian Frericks
Director Investor Relations
Carl Zeiss Meditec AG
Phone: +49 3641 220 116
Mail: investors.med@zeiss.com

Contact for the press
Frank Smith
Head of Global Communications Ophthalmology
Carl Zeiss Meditec Inc.
Phone: +49 3641 220 331
Mail: press.med@zeiss.com

www.zeiss.com/newsroom 

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SOURCE Carl Zeiss Meditec AG

FAQ

What are the key features of ZEISS VISUMAX 800's approval in China?

VISUMAX 800 is approved for treating nearsightedness with/without astigmatism, featuring 2 MHz laser pulse rate, sub-10 second treatment time, and advanced workflow enhancements.

How many eyes have been treated with ZEISS SMILE technology globally?

Over 10 million eyes have been treated with ZEISS SMILE and SMILE pro worldwide, with strong adoption across Asia, Europe, and the U.S.

What workflow improvements does the VISUMAX 800 offer to surgeons?

It includes CentraLign centration aid, OcuLign cyclotorsion adjustment, and VISULYZE user nomograms for data collection and analysis.

How much faster is the treatment with VISUMAX 800's new technology?

The system creates the lenticule in less than 10 seconds using a 2 MHz laser pulse repetition rate.

Carl Zeiss Medit

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