Tomey Optical Biometer OA-2000 (OA-2000)
FDA 510(k) K252348 · Tomey Corporation
510(k) numberK252348
Submission
- Device name
- Tomey Optical Biometer OA-2000 (OA-2000)
- Applicant
- Tomey Corporation
Nagoya, JP - Received
- July 29, 2025
- Decision date
- December 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXK – Device, Analysis, Anterior Segment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
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| K191051 | ArgosMXK · Traditional | Santec Corporation | 05/16/2019SE |
| K152311 | Pentacam AXLMXK · Traditional | Oculus Optikgerate GmbH | 01/20/2016SE |
| K150754 | ArgosMXK · Traditional | Santec Corporation | 10/02/2015SE |
More from Santec Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2)OBO · Traditional | 07/18/2025SE |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2OBO · Traditional | 04/27/2022SE |
| K171313 | EM-4000 Specular MicroscopeNQE · Traditional | 01/19/2018SE |
| K073087 | Non-Contact Tonometer, Model FT-1000HKX · Traditional | 11/18/2008SE |
| K012803 | AL-2000 Combined Biometer and PachymeterIYO · Traditional | 04/08/2002SE |
Questions and answers
When was Tomey Optical Biometer OA-2000 (OA-2000) cleared by the FDA?
Tomey Optical Biometer OA-2000 (OA-2000) (K252348) received a 510(k) decision of Substantially Equivalent on December 18, 2025, 142 days after the submission was received.
What is the product code of K252348?
The FDA product code is MXK – Device, Analysis, Anterior Segment, a Class II (moderate risk) device regulated under 21 CFR 886.1850.