K233516 is an FDA 510(k) clearance for the Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318). This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).
Submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on May 1, 2024, 182 days after receiving the submission on November 1, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K233516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2023 |
| Decision Date | May 01, 2024 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKY - Tonometer, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |