HKX
- Product code
- HKX
- Device name
- Tonometer, Ac-Powered
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.1930
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 58 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253039 | 2025-11-07 | Topcon Corporation | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | |
| K223739 | 2023-11-08 | Medimaging Integrated Solution, Inc. | VS Tabletop Tonometer |
Official FDA classification page: HKX
Classification and pathway per current FDA publications. Data from openFDA (CC0).