K153694 is an FDA 510(k) clearance for the Icare ic100. 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 April 19, 2016, 118 days after receiving the submission on December 23, 2015.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K153694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2015 |
| Decision Date | April 19, 2016 |
| Days to Decision | 118 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 |