K250553 is an FDA 510(k) clearance for the Tomey Cornea/Anterior Segment OCT (CASIA2). This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Tomey Corporation (Nagoya, JP). The FDA issued a Cleared decision on July 18, 2025, 143 days after receiving the submission on February 25, 2025.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..
| 510(k) Number | K250553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2025 |
| Decision Date | July 18, 2025 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OBO - Tomography, Optical Coherence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |
| Definition | Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases. |