K253039 is an FDA 510(k) clearance for the AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA. This device is classified as a Tonometer, Ac-powered (Class II - Special Controls, product code HKX).
Submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 7, 2025, 46 days after receiving the submission on September 22, 2025.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K253039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2025 |
| Decision Date | November 07, 2025 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKX - Tonometer, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |