K142417 is an FDA 510(k) clearance for the SP-1PSpecular Microscope. This device is classified as a Microscope, Specular (Class II - Special Controls, product code NQE).
Submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on May 29, 2015, 274 days after receiving the submission on August 28, 2014.
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 | K142417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2014 |
| Decision Date | May 29, 2015 |
| Days to Decision | 274 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. |