The following data is part of a premarket notification filed by Diomed, Ltd. with the FDA for Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30.
| Device ID | K051996 |
| 510k Number | K051996 |
| Device Name: | DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOMED, LTD. CAMBRIDGE RESEARCH PARK Cambridge, GB Cb5 9te |
| Contact | Tim Phipps |
| Correspondent | Tim Phipps DIOMED, LTD. CAMBRIDGE RESEARCH PARK Cambridge, GB Cb5 9te |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-25 |
| Decision Date | 2005-08-18 |
| Summary: | summary |