K133358 is an FDA 510(k) clearance for the NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Nidek Co., Ltd. (Albignasego (Padova), IT). The FDA issued a Cleared decision on August 12, 2014, 285 days after receiving the submission on October 31, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K133358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2013 |
| Decision Date | August 12, 2014 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF — Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |