The following data is part of a premarket notification filed by Diomed, Inc. with the FDA for Diomed 15 Plus And Diomed 30plus Lasers.
| Device ID | K013499 |
| 510k Number | K013499 |
| Device Name: | DIOMED 15 PLUS AND DIOMED 30PLUS LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOMED, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane DIOMED, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2001-11-16 |
| Summary: | summary |