The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Model Yc-1200.
| Device ID | K893987 |
| 510k Number | K893987 |
| Device Name: | NIDEK MODEL YC-1200 |
| 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 | Janet Mccomb |
| Correspondent | Janet Mccomb 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 | 1989-06-05 |
| Decision Date | 1989-08-18 |