Tomey Cornea/Anterior Segment OCT (CASIA2)
FDA 510(k) K250553 · Tomey Corporation
510(k) numberK250553
Submission
- Device name
- Tomey Cornea/Anterior Segment OCT (CASIA2)
- Applicant
- Tomey Corporation
Nagoya, JP - Received
- February 25, 2025
- Decision date
- July 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBO – Tomography, Optical Coherence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Other 510(k)s with product code OBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261019 | AnterionOBO · Traditional | Heidelberg Engineering GmbH | 09/11/2026SE |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleOBO · Traditional | Heidelberg Engineering GmbH | 05/07/2026SE |
| K252633 | Unity DX (Udx)OBO · Traditional | Cylite Pty. , Ltd. | 12/23/2025SE |
| K250868 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | Heidelberg Engineering GmbH | 05/12/2025SE |
| K240924 | AnterionOBO · Traditional | Heidelberg Engineering GmbH | 12/13/2024SE |
| K241163 | SPECTRALIS with Flex ModuleOBO · Traditional | Heidelberg Engineering GmbH | 10/11/2024SE |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional | Topcon Corporation | 07/17/2024SE |
| K240221 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | Heidelberg Engineering GmbH | 07/01/2024SE |
| K233933 | CIRRUS HD-OCT Model 6000OBO · Traditional | Carl Zeiss Meditec, Inc. | 05/17/2024SE |
| K233602 | P200TE (A10700)OBO · Traditional | Optos Plc. | 05/09/2024SE |
More from Optos Plc.
| 510(k) | Device | Decision |
|---|---|---|
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000)MXK · Traditional | 12/18/2025SE |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2OBO · Traditional | 04/27/2022SE |
| K171313 | EM-4000 Specular MicroscopeNQE · Traditional | 01/19/2018SE |
| K073087 | Non-Contact Tonometer, Model FT-1000HKX · Traditional | 11/18/2008SE |
| K012803 | AL-2000 Combined Biometer and PachymeterIYO · Traditional | 04/08/2002SE |
Questions and answers
When was Tomey Cornea/Anterior Segment OCT (CASIA2) cleared by the FDA?
Tomey Cornea/Anterior Segment OCT (CASIA2) (K250553) received a 510(k) decision of Substantially Equivalent on July 18, 2025, 143 days after the submission was received.
What is the product code of K250553?
The FDA product code is OBO – Tomography, Optical Coherence, a Class II (moderate risk) device regulated under 21 CFR 886.1570.