The following data is part of a premarket notification filed by Diomed, Inc. with the FDA for A100 Aesthetic Diode Laser.
| Device ID | K000982 |
| 510k Number | K000982 |
| Device Name: | A100 AESTHETIC DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOMED, INC. 1 WING RD. Lynnfield, MA 01940 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell DIOMED, INC. 1 WING RD. Lynnfield, MA 01940 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-05-01 |