OBO

Tomography, Optical Coherence

Product code
OBO
Device name
Tomography, Optical Coherence
Device class
Class 2
21 CFR
21 CFR 886.1570
Medical specialty
Ophthalmic
Marketing pathway
510(K)
510(k) clearances (last 3 years)
15
Summaries archived here
14 (direct download)
510(k) clearances (all years, FDA)
66 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (15)

Last three years. Most recent: 2026-05-07.

NumberDecision dateApplicantDevice nameSummary
K2538372026-05-07Heidelberg Engineering GmbHSPECTRALIS HRA+OCT and variants; SPECTRALIS with Fle…FDA
K2526332025-12-23Cylite Pty. , Ltd.UNITY DX (UDX)PDF
K2505532025-07-18Tomey CorporationTomey Cornea/Anterior Segment OCT (CASIA2)PDF
K2508682025-05-12Heidelberg Engineering GmbHSPECTRALIS HRA+OCT and variantsPDF
K2409242024-12-13Heidelberg Engineering GmbHAnterionPDF
K2411632024-10-11Heidelberg Engineering GmbHSPECTRALIS with Flex ModulePDF
K2410812024-07-17Topcon Corporation3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maes…PDF
K2402212024-07-01Heidelberg Engineering GmbHSPECTRALIS HRA+OCT and variantsPDF
K2339332024-05-17Carl Zeiss Meditec, Inc.CIRRUS™ HD-OCT Model 6000PDF
K2336022024-05-09Optos Plc.P200TE (A10700)PDF
K2335612024-04-10Topcon Corporation3D Optical Coherence Tomography (3D OCT-1(type: Maes…PDF
K2334212024-03-08Carl Zeiss Meditec, AGRESCAN 700PDF
K2312222023-10-30Topcon Corporation3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maest…PDF
K2235572023-10-20Heidelberg Engineering GmbHSPECTRALIS HRA+OCT and variantsPDF
K2308972023-10-11Heidelberg Engineering GmbHAnterionPDF

14 summaries are archived here for direct download.

Official FDA classification page: OBO
Classification and pathway per current FDA publications. Data from openFDA (CC0).