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 Heidelberg Engineering GmbH, Topcon Corporation and Optos Plc..
FDA 510(k) Cleared Tomography, Optical Coherence Devices (Product Code OBO)
About Product Code OBO - Regulatory Context
510(k) Submission Activity
65 total 510(k) submissions under product code OBO since 2006, with 65 receiving FDA clearance (average review time: 173 days).
Submission volume has declined in recent years - 8 submissions in the last 24 months compared to 11 in the prior period.
FDA Review Time
Recent submissions under OBO have taken an average of 142 days to reach a decision - down from 178 days historically, suggesting improved FDA processing for this classification.
OBO devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →