DeviceClearance

Product code OBO— Ophthalmic

Anterion

Classification name
Tomography, Optical Coherence
Device class
Class 2
Regulation
21 CFR 886.1570
Advisory panel
Ophthalmic
Total cleared
67
First cleared
Most recent

FDA classification definition

“Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.”

— U.S. Food and Drug Administration, device classification record for product code OBO under 21 CFR 886.1570, via openFDA

Market context for product code OBO

FDA has cleared 67 devices under product code OBO between 2006 and 2026, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OBO

Recent clearances under product code OBO

Data sourced from openFDA. This site is unofficial and independent of the FDA.