K163343 is an FDA 510(k) clearance for the Icare HOME tonometer. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).
Submitted by Icare Finland OY (Vantaa, FI). The FDA issued a Cleared decision on March 21, 2017, 112 days after receiving the submission on November 29, 2016.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K163343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2016 |
| Decision Date | March 21, 2017 |
| Days to Decision | 112 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 |