K191558 is an FDA 510(k) clearance for the Konan Specular Microscope XVII. This device is classified as a Microscope, Specular (Class II - Special Controls, product code NQE).
Submitted by Konan Medical, Inc. (Nishinomiya, JP). The FDA issued a Cleared decision on March 26, 2020, 288 days after receiving the submission on June 12, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850. Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro..
| 510(k) Number | K191558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2019 |
| Decision Date | March 26, 2020 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NQE - Microscope, Specular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |
| Definition | Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro. |