K120264 is an FDA 510(k) clearance for the KONAN SPECULAR MICROSCOPE XIV. This device is classified as a Microscope, Specular (Class II - Special Controls, product code NQE).
Submitted by Konan Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on April 11, 2012, 72 days after receiving the submission on January 30, 2012.
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 | K120264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2012 |
| Decision Date | April 11, 2012 |
| Days to Decision | 72 days |
| Submission Type | Special |
| 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. |