The following data is part of a premarket notification filed by Nidek Incorporated with the FDA for Nidek Multicolor Laser Photocoagulator.
| Device ID | K110228 |
| 510k Number | K110228 |
| Device Name: | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR |
| Classification | Photocoagulator And Accessories |
| Applicant | NIDEK INCORPORATED 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan NIDEK INCORPORATED 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Product Code | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-26 |
| Decision Date | 2011-02-23 |
| Summary: | summary |