The following data is part of a premarket notification filed by Medart A/s with the FDA for Medart Diode Laser System & Accessories.
| Device ID | K110243 |
| 510k Number | K110243 |
| Device Name: | MEDART DIODE LASER SYSTEM & ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDART A/S CLOS LLYN CWM Swansea, Wales, GB Sa6 8qy |
| Contact | Joanne Davies |
| Correspondent | Joanne Davies MEDART A/S CLOS LLYN CWM Swansea, Wales, GB Sa6 8qy |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-27 |
| Decision Date | 2011-06-28 |
| Summary: | summary |