FDA Product Code OBO: Tomography, Optical Coherence
Optical coherence tomography provides microscopic-resolution imaging of ocular structures. FDA product code OBO covers OCT systems used in ophthalmology for retinal and anterior segment imaging.
These devices use near-infrared light interference to generate cross-sectional images of the retina, optic nerve, and anterior chamber at near-histological resolution. OCT has transformed the diagnosis and management of macular degeneration, glaucoma, and diabetic retinopathy.
OBO devices are Class II medical devices, regulated under 21 CFR 886.1570 and reviewed by the FDA Ophthalmic panel.
Leading manufacturers include Carl Zeiss Meditec, Inc., Nidek Co., Ltd. and Carl Zeiss Meditec, AG.
List of Tomography, Optical Coherence devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Tomography, Optical Coherence devices (product code OBO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Ophthalmic FDA review panel. Browse all Ophthalmic devices →