OBOClass II

Tomography, Optical Coherence

21 CFR 886.1570 / Ophthalmic

OBO is the FDA product code for Tomography, Optical Coherence, a class II device type, regulated under 21 CFR 886.1570. FDA's definition for this code reads: "Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases". As of 2026-09-10, FDA records hold 66 510(k) clearances under this code, the most recent dated 2026-05-07, and 11 recalls.

Classification record

Product code: OBO
Device name: Tomography, Optical Coherence
FDA definition: Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Regulation: 21 CFR 886.1570
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 67
Ingested recalls: 12

Clearances, product code OBO

By decision year

67 clearances under product code OBO with a decision year between 2006 and 2026, 2024 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code OBO by decision year
Year	Clearances
2006	2
2007	2
2008	2
2009	4
2010	2
2011	2
2012	3
2013	2
2014	3
2015	1
2016	4
2017	4
2018	6
2019	5
2020	2
2021	1
2022	2
2023	7
2024	8
2025	3
2026	2

Applicants with the most clearances

Product code OBO

Applicants holding the most 510(k) clearances under product code OBO
Applicant	Clearances
Heidelberg Engineering GmbH	19
Carl Zeiss Meditec Inc	12
Topcon Corp.	8
Optovue Inc.	7
Optos PLC.	4
Nidek Co., Ltd.	2
Topcon Healthcare, Inc.	2
Bioptigen, Inc.	1
C.S.O. S.r.l.	1
Canon, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order