The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Prima Model Gyc-1500/2000.
| Device ID | K980547 |
| 510k Number | K980547 |
| Device Name: | NIDEK PRIMA MODEL GYC-1500/2000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
| Contact | Ken Kato |
| Correspondent | Ken Kato NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-12 |
| Decision Date | 1998-05-13 |
| Summary: | summary |