The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek, Inc. Bio-dc Laser Delivery System.
| Device ID | K900165 |
| 510k Number | K900165 |
| Device Name: | NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIDEK, INC. CRC ASSOCIATES 25422 TRABUCO ROAD#105-253 El Toro, CA 92630 |
| Contact | Mccomb, Ph.d. |
| Correspondent | Mccomb, Ph.d. NIDEK, INC. CRC ASSOCIATES 25422 TRABUCO ROAD#105-253 El Toro, 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 | 1990-01-12 |
| Decision Date | 1990-03-22 |