K171313 is an FDA 510(k) clearance for the EM-4000 Specular Microscope. This device is classified as a Microscope, Specular (Class II - Special Controls, product code NQE).
Submitted by Tomey Corporation (Nagoya, JP). The FDA issued a Cleared decision on January 19, 2018, 260 days after receiving the submission on May 4, 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 | K171313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2017 |
| Decision Date | January 19, 2018 |
| Days to Decision | 260 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. |