The following data is part of a premarket notification filed by Dio-med Corp. with the FDA for Diomed 25 25w Surgical Diode Laser.
| Device ID | K931212 |
| 510k Number | K931212 |
| Device Name: | DIOMED 25 25W SURGICAL DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIO-MED CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | C/o Mdci |
| Correspondent | C/o Mdci DIO-MED CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-10 |
| Decision Date | 1993-09-23 |