Auto Kerato-Refracto Tonometer TRK-3 Omnia
FDA 510(k) K253039 · Topcon Corporation
510(k) numberK253039
Submission
- Device name
- Auto Kerato-Refracto Tonometer TRK-3 Omnia
- Applicant
- Topcon Corporation
Tokyo, JP - Received
- September 22, 2025
- Decision date
- November 7, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKX – Tonometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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| K111710 | Full Auto Tonometer Model TX-20HKX · Special | Canon Inc. -Medical Equipment Group | 09/20/2011SE |
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| K232828 | IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional | 03/01/2024SE |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)OBO · Traditional | 10/30/2023SE |
| K221111 | Non-Mydriatic Retinal Camera NW500HKI · Traditional | 08/29/2022SE |
| K173119 | DRI OCT TritonOBO · Traditional | 01/19/2018SE |
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| K170164 | 3D OCT-1 MaestroOBO · Special | 03/03/2017SE |
| K161972 | Slit Lamp SL-D301HJO · Traditional | 12/09/2016SE |
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Questions and answers
When was Auto Kerato-Refracto Tonometer TRK-3 Omnia cleared by the FDA?
Auto Kerato-Refracto Tonometer TRK-3 Omnia (K253039) received a 510(k) decision of Substantially Equivalent on November 7, 2025, 46 days after the submission was received.
What is the product code of K253039?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.