The following data is part of a premarket notification filed by Diomed, Inc. with the FDA for Evlt Kit And The D15plus And D30plus Diode Lasers.
| Device ID | K041957 |
| 510k Number | K041957 |
| Device Name: | EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOMED, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell DIOMED, INC. 5 TIMBER LANE 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 | 2004-07-21 |
| Decision Date | 2004-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787EVLTPVAK0 | K041957 | 000 |
| H787EVLT80OPS0 | K041957 | 000 |
| H787EVLT55OPS0 | K041957 | 000 |
| H787EVLT25OPS0 | K041957 | 000 |
| 15051684020848 | K041957 | 000 |