The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Models Ac-2100 & 2200.
| Device ID | K913465 |
| 510k Number | K913465 |
| Device Name: | NIDEK MODELS AC-2100 & 2200 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | Ken Kato |
| Correspondent | Ken Kato NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-05 |
| Decision Date | 1991-10-21 |