The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Dc-3300 Laser Diode Photocoagulator.
| Device ID | K013760 |
| 510k Number | K013760 |
| Device Name: | DC-3300 LASER DIODE PHOTOCOAGULATOR |
| Classification | Laser, Ophthalmic |
| 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 | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-02-11 |
| Summary: | summary |