News

ZEISS Gains FDA Approval for MEL 90 Laser, Expands Refractive Surgery Portfolio in U.S.

• By John K. Waters
• 01/15/2025

ZEISS Medical Technology announced on Tuesday that its MEL 90 excimer laser has received approval from the U.S. Food and Drug Administration (FDA), granting it simultaneous approval for treating myopia, hyperopia, and mixed astigmatism. The FDA clearance positions the device as a versatile addition to the U.S. refractive surgery market, aiming to enhance patient outcomes and surgical efficiency.

The MEL 90 integrates seamlessly into ZEISS’s Corneal Refractive Workflow, complementing the VISUMAX 800 femtosecond laser with SMILE pro. The company says the combination offers surgeons an expanded toolkit to attract more patients and achieve better clinical results.

"The increasing global adoption of laser vision correction reflects the advancements and positive impact the technology continues to have on the quality of life for patients," said Magnus Reibenspiess, Head of Strategic Business Unit Ophthalmology at ZEISS Medical Technology, in a statement. "With the integration of the ZEISS MEL 90, surgeons can confidently care for their patients with greater workflow efficiency and performance with enhanced outcomes."

Andrew Chang, Head of Global Sales for ZEISS Medical Technology, emphasized the company’s commitment to supporting U.S. surgeons and patients. "ZEISS continues to break new ground as a leader in the laser vision correction (LVC) market," he said. "With the availability of the ZEISS MEL 90 in the U.S. market, surgeons can now offer an integrated workflow of refractive technology to help reach new patients and provide excellent outcomes for them."

Dr. John Doane, a refractive surgeon at Discover Vision Centers in Kansas City, MO, lauded the FDA approval as a milestone for the industry. "The ZEISS MEL 90 excimer laser is a game changer for refractive surgery in the U.S.," Doane said. "This advanced technology, with its Triple-A ablation algorithm and fast ablation speed, sets a new benchmark for precision, safety, and efficiency."

The MEL 90’s Triple-A (Advanced Ablation Algorithm) feature simplifies treatment planning with a single ablation profile for a wide range of sphero-cylindrical corrections. According to ZEISS, this feature enhances accuracy, reproducibility, and predictability, while conserving tissue during procedures. The system also offers pre-installed functions to support treatments for standard, high, and low levels of ametropia and astigmatism.

The MEL 90 can perform LASIK for myopia at 500 Hz, enabling intraoperative ablation of 1 diopter in just 1.3 seconds. Its active eye tracker ensures precise alignment, while intuitive system guidance and fast treatment planning streamline procedures.

The device’s ergonomic design aims to improve surgeon comfort, with a flexible touch-screen interface and customizable configuration options. Additional workflow enhancements include an HD video port, network printer connection, and PDF export capabilities.

The FDA approval of the ZEISS MEL 90 is expected to strengthen ZEISS’s position in the U.S. refractive surgery market, providing surgeons with an integrated solution for expanding their patient base and achieving superior outcomes. As the demand for laser vision correction grows, the MEL 90 is poised to play a significant role in meeting patient and surgeon needs alike.