K180895 is an FDA 510(k) clearance for the Alleye. This device is classified as a Grid, Amsler (Class I - General Controls, product code HOQ).
Submitted by Oculocare Medical AG (Zurich, CH). The FDA issued a Cleared decision on June 27, 2018, 83 days after receiving the submission on April 5, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1330.
| 510(k) Number | K180895 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2018 |
| Decision Date | June 27, 2018 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HOQ — Grid, Amsler |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1330 |