The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Nidek Multicolor Scan Laser Photocoagulator Mc-500 Vixi.
| Device ID | K111493 |
| 510k Number | K111493 |
| Device Name: | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI |
| Classification | Photocoagulator And Accessories |
| Applicant | NIDEK CO., LTD. 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale, CA 94085 |
| Contact | Michael J Billig |
| Correspondent | Michael J Billig NIDEK CO., LTD. 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale, CA 94085 |
| Product Code | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-31 |
| Decision Date | 2011-07-27 |