The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Ophthalmic Yag Laser System Yc-200.
| Device ID | K192045 |
| 510k Number | K192045 |
| Device Name: | Ophthalmic Yag Laser System YC-200 |
| Classification | Laser, Ophthalmic |
| Applicant | Nidek Co., Ltd. 34-14 Maehama, Hiroishicho Gamagori, JP 443-0038 |
| Contact | Tsutomu Sunada |
| Correspondent | Todd Milholland Nidek Incorporated 2040 Corporate Court San Jose, CA 95131 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-31 |
| Decision Date | 2019-11-15 |