Carl Zeiss Meditec, Inc. - FDA 510(k) Cleared Devices

Carl Zeiss Meditec, Inc. is a global medical device manufacturer specializing in innovative solutions for ophthalmology and microsurgery. The company operates with a manufacturing facility in San Diego, California, and is part of the ZEISS Group, a leader in optical and optoelectronic technologies since 1846.

The company maintains a strong FDA 510(k) regulatory record with 29 FDA 510(k) clearances from 29 total submissions. Ophthalmic devices represent the dominant focus, accounting for approximately 86% of submissions. Carl Zeiss Meditec has been active in FDA clearances since 1993, with the most recent clearance in 2025, demonstrating continued innovation and market presence.

The company's cleared device portfolio includes optical coherence tomography (OCT) systems, femtosecond lasers, corneal topographers, and diagnostic imaging platforms. These products serve ophthalmologists, optometrists, and surgical specialists worldwide, supporting diagnostic and therapeutic procedures across multiple ophthalmic specialties.

Explore the complete list of device names, product codes, and individual clearance dates in the FDA 510(k) database.

510(k) submissions have been managed by Carl Zeiss Meditec USA, Inc. as regulatory consultant.