Carl Zeiss Meditec - FDA 510(k) Cleared Devices

Carl Zeiss Meditec, is a global medical technology company specializing in ophthalmic solutions. The company develops diagnostic and surgical instruments for eye care professionals worldwide, with a manufacturing facility in Dublin, US.

Carl Zeiss Meditec has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory activity is focused entirely on ophthalmic devices. The most recent clearance dates to 2023, representing the company's historical FDA record.

The company's cleared device portfolio includes the VISULAS green system, a laser-based ophthalmic instrument. Carl Zeiss Meditec is part of the broader ZEISS Group, a research-oriented enterprise with over 175 years of optical innovation. The company maintains a global presence across vision care, medical technology, and precision optics sectors.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.