K151706 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 17, 2016, 267 days after receiving the submission on June 24, 2015.
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 | K151706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2015 |
| Decision Date | March 17, 2016 |
| Days to Decision | 267 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. |