The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Epi-star Surgical Laser Syster.
| Device ID | K990119 |
| 510k Number | K990119 |
| Device Name: | EPI-STAR SURGICAL LASER SYSTER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIDEK, INC. 47651 WESTINGHOUSE DR. Fremont, CA 94539 |
| Contact | Jerry Tsutsumi |
| Correspondent | Jerry Tsutsumi 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 | 1999-01-13 |
| Decision Date | 2000-07-27 |
| Summary: | summary |