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OBO — Tomography, Optical Coherence Class II

FDA Device Classification

Classification Details

Product Code
OBO
Device Class
Class II
Regulation Number
886.1570
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252633cylite pty.UNITY DX (UDX)December 23, 2025
K250553tomey corporationTomey Cornea/Anterior Segment OCT (CASIA2)July 18, 2025
K250868heidelberg engineeringSPECTRALIS HRA+OCT and variantsMay 12, 2025
K240924heidelberg engineeringAnterionDecember 13, 2024
K241163heidelberg engineeringSPECTRALIS with Flex ModuleOctober 11, 2024
K241081topcon corporation3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic July 17, 2024
K240221heidelberg engineeringSPECTRALIS HRA+OCT and variantsJuly 1, 2024
K233933carl zeiss meditecCIRRUS™ HD-OCT Model 6000May 17, 2024
K233602optosP200TE (A10700)May 9, 2024
K233561topcon corporation3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))April 10, 2024
K233421carl zeiss meditecRESCAN 700March 8, 2024
K231222topcon corporation3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)October 30, 2023
K223557heidelberg engineeringSPECTRALIS HRA+OCT and variantsOctober 20, 2023
K230897heidelberg engineeringAnterionOctober 11, 2023
K221601c.s.oMS-39September 1, 2023
K231673optosP200TE (A10700)August 18, 2023
K222200carl zeiss meditecCIRRUS HD-OCTApril 13, 2023
K221320nidek coScanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing SoftwareMarch 30, 2023
K222166optovueSOLIXNovember 9, 2022
K213265tomey corporationTomey Cornea/Anterior Segment OCT CASIA2April 27, 2022