K111493 is an FDA 510(k) clearance for the NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI. This device is classified as a Photocoagulator And Accessories (Class II - Special Controls, product code HQB).
Submitted by Nidek Co., Ltd. (Sunnyvale, US). The FDA issued a Cleared decision on July 27, 2011, 57 days after receiving the submission on May 31, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4690.
| 510(k) Number | K111493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2011 |
| Decision Date | July 27, 2011 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQB — Photocoagulator And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4690 |