The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Adc-8000 Laser System.
| Device ID | K872846 |
| 510k Number | K872846 |
| Device Name: | NIDEK ADC-8000 LASER SYSTEM |
| Classification | Laser, Ophthalmic |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | Vertis Hagan |
| Correspondent | Vertis Hagan NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-20 |
| Decision Date | 1987-10-15 |