The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Yellow Laser Photocoagulator Ylc-500.
| Device ID | K170302 |
| 510k Number | K170302 |
| Device Name: | YELLOW LASER PHOTOCOAGULATOR YLC-500 |
| Classification | Laser, Ophthalmic |
| Applicant | NIDEK CO., LTD. 34-14 Maehama, Hiroishicho Gamagori, JP 443-0038 |
| Contact | Yoneji Mizuno |
| Correspondent | Toshio Murata NIDEK INCORPORATED 47651 Westinghouse Drive Fremont, CA 94539 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-31 |
| Decision Date | 2017-06-23 |
| Summary: | summary |