Medical Device Manufacturer · US , Woodinville , WA

Oculus Optikgerate GmbH - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2003

Recent clearances: Pentacam AXL Wave, Pentacam AXL, CORVIS ST

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Oculus Optikgerate GmbH Ophthalmic ✕

6 devices

1-6 of 6

Cleared Oct 21, 2020

Pentacam AXL Wave

Ophthalmic · 120d

Cleared Jan 20, 2016

Ophthalmic · 159d

Cleared Nov 08, 2012

Ophthalmic · 388d

Cleared Sep 11, 2008

Ophthalmic · 273d

Cleared Jan 28, 2005

Ophthalmic · 204d

Cleared Sep 16, 2003

PENTACAM SCHEIMPFLUG CAMERA

Ophthalmic · 193d

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: May 28, 2026