The following data is part of a premarket notification filed by Nidek Co., Ltd with the FDA for Nidek Multicolor Laser Photocoagulator System Mc-500 Connected With The Endophotocoagulation Delivery Unit.
| Device ID | K133358 |
| 510k Number | K133358 |
| Device Name: | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT |
| Classification | Laser, Ophthalmic |
| Applicant | NIDEK CO., LTD VIA DELL'ARTIGIANATO, 6/A Albignasego, IT 35020 |
| Contact | Enrico Bisson |
| Correspondent | Enrico Bisson NIDEK CO., LTD VIA DELL'ARTIGIANATO, 6/A Albignasego, IT 35020 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-31 |
| Decision Date | 2014-08-12 |
| Summary: | summary |