The following data is part of a premarket notification filed by Diomed, Ltd. with the FDA for Diomed 15 Diode Laser.
| Device ID | K012398 |
| 510k Number | K012398 |
| Device Name: | DIOMED 15 DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOMED, LTD. 5 TIMBER LN. North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell DIOMED, LTD. 5 TIMBER LN. North Reading, MA 01864 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-27 |
| Decision Date | 2002-01-22 |
| Summary: | summary |