Medical Device Manufacturer · US , San Diego , CA

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

29 submissions · 29 cleared · Since 1993

Recent clearances: CLARUS (700), CIRRUS™ HD-OCT Model 6000, VISULAS yag

Official Website

29

Total

29

Cleared

0

Denied

FDA 510(k) Regulatory Record - Carl Zeiss Meditec, Inc. Ophthalmic ✕

25 devices

1-12 of 25

Cleared Apr 17, 2025

Ophthalmic · 120d

Cleared May 17, 2024

CIRRUS™ HD-OCT Model 6000

Ophthalmic · 155d

Cleared Sep 22, 2023

Ophthalmic · 225d

Cleared Apr 13, 2023

Ophthalmic · 262d

Cleared Jun 25, 2019

Ophthalmic · 53d

Cleared Feb 15, 2019

Ophthalmic · 249d

Cleared Jan 10, 2019

Ophthalmic · 223d

Cleared Oct 24, 2018

Retina Workplace

Ophthalmic · 58d

Cleared Apr 13, 2018

VisuMax Femtosecond Laser

Ophthalmic · 168d

Cleared Oct 26, 2016

PLEX Elite 9000 SS-OCT

Ophthalmic · 182d

Cleared Sep 01, 2015

Ophthalmic · 141d

Cleared Jul 10, 2015

Ophthalmic · 238d