The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Inc. Models Yc-2000 & 3000 Ophthalmic Lasers.
| Device ID | K892204 |
| 510k Number | K892204 |
| Device Name: | NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS |
| Classification | Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Applicant | NIDEK, INC. CRC ASSOCIATES 25422 TRABUCO ROAD#105-253 El Toro, CA 92630 |
| Contact | Crc Associates |
| Correspondent | Crc Associates NIDEK, INC. CRC ASSOCIATES 25422 TRABUCO ROAD#105-253 El Toro, CA 92630 |
| Product Code | LXS |
| CFR Regulation Number | 886.4392 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-06-22 |