The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Green Laser Photocoagulator Model Gyc-1000.
| Device ID | K032085 |
| 510k Number | K032085 |
| Device Name: | GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson NIDEK, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-07 |
| Decision Date | 2003-10-03 |
| Summary: | summary |