The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Model Gyc-1500 And Gyc-2000.
| Device ID | K951079 |
| 510k Number | K951079 |
| Device Name: | NIDEK MODEL GYC-1500 AND GYC-2000 |
| Classification | Laser, Ophthalmic |
| 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 | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-09-14 |