K130565 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. (Andover, US). The FDA issued a Cleared decision on November 27, 2013, 268 days after receiving the submission on March 4, 2013.
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 | K130565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2013 |
| Decision Date | November 27, 2013 |
| Days to Decision | 268 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. |