The following data is part of a premarket notification filed by Tomey Corporation with the FDA for Tomey Cornea/anterior Segment Oct Casia2.
| Device ID | K213265 |
| 510k Number | K213265 |
| Device Name: | Tomey Cornea/Anterior Segment OCT CASIA2 |
| Classification | Tomography, Optical Coherence |
| Applicant | Tomey Corporation 2-11-33 Noritakeshinmachi Nishi-ku, JP 451-0051 |
| Contact | Yuko Matsushita |
| Correspondent | Ryan Bouchard ORA, Inc. 300 Brickstone Square Andover, MA 01801 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582273604704 | K213265 | 000 |