The following data is part of a premarket notification filed by Vision Lasertechnik, Gmbh with the FDA for Mdl Series Diode Lasers, Model Mdl-10/15.
| Device ID | K042114 |
| 510k Number | K042114 |
| Device Name: | MDL SERIES DIODE LASERS, MODEL MDL-10/15 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | VISION LASERTECHNIK, GMBH 8135 S. BEAUMONT DR. Sandy, UT 84093 |
| Contact | Robert S Head |
| Correspondent | Robert S Head VISION LASERTECHNIK, GMBH 8135 S. BEAUMONT DR. Sandy, UT 84093 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-05 |
| Decision Date | 2006-02-03 |