K173980 is an FDA 510(k) clearance for the Specular Microscope CEM-530. This device is classified as a Microscope, Specular (Class II - Special Controls, product code NQE).
Submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on March 14, 2018, 75 days after receiving the submission on December 29, 2017.
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 | K173980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2017 |
| Decision Date | March 14, 2018 |
| Days to Decision | 75 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. |