The following data is part of a premarket notification filed by Dio-med Corp. with the FDA for Diomed 25 Surgical Diode Laser, Gynecology Applic.
| Device ID | K914519 |
| 510k Number | K914519 |
| Device Name: | DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLIC |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIO-MED CORP. ST. JOHN'S INNOVATION PARK COWLEY ROAD Cambridge Cb4 4ws England, GB |
| Contact | Ilkka Mannonen |
| Correspondent | Ilkka Mannonen DIO-MED CORP. ST. JOHN'S INNOVATION PARK COWLEY ROAD Cambridge Cb4 4ws England, GB |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-10 |
| Decision Date | 1993-09-16 |