Tomey Corporation · Class II · Cleared Jul 18, 2025
| K-number | K250553 |
| Device name | Tomey Cornea/Anterior Segment OCT (CASIA2) |
| Applicant | Tomey Corporation |
| Product code | OBO |
| Device class | Class II |
| Decision date | Jul 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 886.1570 |
The Tomey CASIA2 is a non-contact, high-resolution optical coherence tomography (OCT) device for in vivo imaging and measurement of anterior segment ocular structures. It measures corneal thickness, anterior chamber depth, and lens thickness to assist in clinical evaluation and surgical planning.
The CASIA2 uses swept-source OCT technology at 1310 nm wavelength with a 50,000 A-scan/s scan rate and less than 6 mW power output, providing axial resolution of 10 μm or less and transverse resolution of 30 μm or less. It is identical in hardware to the predicate K213265 but features updated software to provide quantitative measurements derived from OCT images.
ISO 10993-1:2018 (biocompatibility), IEC 60601-1 Ed.3.2 (electrical safety), IEC 60601-1-2 Ed.4.1 (electromagnetic compatibility), ANSI Z80.36:2021 (laser safety), and ISO 14971:2019 (risk assessment). Software documentation followed FDA guidance for medical device software.
The CASIA2 maintains identical intended use and swept-source OCT technology as the predicate K213265, with the same wavelength, scan rate, power output, and measurement field of view. The software enhancement adds quantitative outputs (CCT, ACD, LT) that are derived from the predicate's existing OCT imaging without introducing new safety or effectiveness risks. Clinical testing with 224 subjects demonstrated agreement and precision with the reference device LENSTAR LS900 across multiple populations, confirming that quantitative measurements align with established devices without raising new safety concerns.
View the full FDA submission: accessdata.fda.gov