K211355 is an FDA 510(k) clearance for the iCare HOME2. 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 January 25, 2022, 267 days after receiving the submission on May 3, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K211355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2021 |
| Decision Date | January 25, 2022 |
| Days to Decision | 267 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 |