K062763 is an FDA 510(k) clearance for the NONCON ROBO PACHY F&A. This device is classified as a Microscope, Specular (Class II - Special Controls, product code NQE).
Submitted by Konan Medical, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on February 22, 2008, 525 days after receiving the submission on September 15, 2006.
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 | K062763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2006 |
| Decision Date | February 22, 2008 |
| Days to Decision | 525 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. |