The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Mydon C.
| Device ID | K040384 |
| 510k Number | K040384 |
| Device Name: | MYDON C |
| Classification | Powered Laser Surgical Instrument |
| Applicant | WAVELIGHT LASER TECHNOLOGIE AG 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell WAVELIGHT LASER TECHNOLOGIE AG 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-05-14 |
| Summary: | summary |