Optos Plc. - FDA 510(k) Cleared Devices

Optos Plc., is a leading developer of ultra-widefield retinal imaging systems for eyecare professionals. The company specializes in innovative diagnostic devices that capture panoramic retinal images in a single shot. Now part of Nikon Corporation, Optos continues to operate as a distinct brand with a manufacturing facility in Washington, US.

Optos has an established FDA 510(k) regulatory record with 15 FDA 510(k) clearances from 15 total submissions. All submissions focus on Ophthalmic devices. The company's first clearance was in 1999, with the most recent clearance in 2024, demonstrating continued innovation and active market presence.

The company's product portfolio includes advanced retinal imaging platforms such as Silverstone RGB, MonacoPro, and California, along with complementary software solutions for image analysis and clinical workflow. These devices incorporate multiple imaging modalities including optical coherence tomography (OCT), autofluorescence, and fluorescein angiography to support comprehensive retinal examination and disease management.

Explore the complete list of Optos Ophthalmic device clearances, including specific product names, model numbers, and clearance dates in the database.

2 devices have linked clinical trials registered on ClinicalTrials.gov.