Products

Medical Devices & Co-Development

MLase develops and manufactures excimer laser systems for medical applications, supporting customers from subsystem integration to complete device development in alignment with application and regulatory requirements.

All systems are designed and manufactured under a certified quality management system in accordance with ISO 13485/ EN ISO 13485.

Regulatory-Driven Development of Excimer Laser Medical Systems

Medical laser systems are developed within tightly controlled regulatory frameworks where design, manufacturing, and documentation must meet defined standards such as ISO 13485/ EN ISO 13485, or MDR requirements. In this environment, laser performance is only one part of a much larger system that must be validated, traceable, and reliable over its full lifecycle.

MLase contributes to this process with excimer laser subsystems and system expertise aligned with medical development requirements. This includes stable and well-characterized laser performance, support for system integration, and an understanding of regulatory expectations in device design and manufacturing.

This section outlines how excimer laser technology is applied in medical device development, with a focus on integration, co-development, and the transition to compliant and manufacturable systems.

How We Can Help You

Integration
OEM Products for Medical Systems

For OEM partners developing medical devices, MLase provides excimer laser subsystems designed for reliable integration into clinically used systems.

Development
Medical Device Realization

For new or advanced applications, MLase supports the development of complete laser-based medical devices, including system architecture, beam delivery and manufacturing.

Medical Capabilities & Partnership 

Co-Development


  • joint development of beam delivery and system concepts
  • application-specific process definition
  • integration into existing or new device architectures

Device Realization


  • development of complete laser-based medical systems
  • experience from clinical applications to market introduction
  • transition to series production and manufacturing

Quality & Regulatory Foundation


  • ISO 13485/ EN ISO 13485 certified organization
  • experience with MDR-compliant systems
  • support for regulatory processes and documentation
  • understanding of FDA-related requirements

Subsystem Supply


  • excimer laser integration into medical devices
  • stable pulse energy and long-term performance
  • designed for clinical operation environments
ISO 13485

Our Commitment to Quality

MLase operates as a medical device manufacturer with a quality management system certified according to ISO 13485/ EN ISO 13485. Our products are developed and manufactured to meet the highest standards of performance, reliability, and quality.

This commitment ensures that our excimer laser systems support safe and dependable operation in demanding medical applications.

Need more Information?

Check out how we ensure regulatory compliance and best in class, laser-based medical systems

Contact Us

Ready to talk about your application needs? Get in contact with our sales team or one of our trained authorized partners