The following data is part of a premarket notification filed by Cardiofocus, Inc. with the FDA for Cardiofocus Diode Laser System, Models 60r, 60nr, 30nr.
| Device ID | K013201 |
| 510k Number | K013201 |
| Device Name: | CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARDIOFOCUS, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum CARDIOFOCUS, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-25 |
| Decision Date | 2002-03-18 |
| Summary: | summary |