The following data is part of a premarket notification filed by Diomed, Inc. with the FDA for Evlt Kit And D15plus And D30plus Diode.
| Device ID | K023543 |
| 510k Number | K023543 |
| Device Name: | EVLT KIT AND D15PLUS AND D30PLUS DIODE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOMED, INC. ONE DUNDEE PARK, SUITES 5&6 PO BOX 97 Andover, MA 01810 |
| Contact | Samuel D Wade |
| Correspondent | Samuel D Wade DIOMED, INC. ONE DUNDEE PARK, SUITES 5&6 PO BOX 97 Andover, MA 01810 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-22 |
| Decision Date | 2002-12-02 |
| Summary: | summary |