K180820 is an FDA 510(k) clearance for the Tono Vue Non-Contact Tonometer. This device is classified as a Tonometer, Ac-powered (Class II - Special Controls, product code HKX).
Submitted by Crystalvue Medical Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on December 14, 2018, 260 days after receiving the submission on March 29, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K180820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2018 |
| Decision Date | December 14, 2018 |
| Days to Decision | 260 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 |