K213265 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 (Nishi-Ku, JP). The FDA issued a Cleared decision on April 27, 2022, 209 days after receiving the submission on September 30, 2021.
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 | K213265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2021 |
| Decision Date | April 27, 2022 |
| Days to Decision | 209 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. |