510(k) K252348 ยท MXK Device, Analysis, Anterior Segment
Tomey Optical Biometer OA-2000 (OA-2000)
| Applicant | Tomey Corporation, Nagoya, JP |
| Decision | Substantially Equivalent, Dec 18, 2025 |
| Received | Jul 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252348
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.