The following data is part of a premarket notification filed by Diomed, Inc. with the FDA for Dioscan.
| Device ID | K990014 |
| 510k Number | K990014 |
| Device Name: | DIOSCAN |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOMED, INC. 30-31 UNION WHARF, 3RD FLR. Boston, MA 02109 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell DIOMED, INC. 30-31 UNION WHARF, 3RD FLR. Boston, MA 02109 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-04 |
| Decision Date | 1999-02-26 |
| Summary: | summary |