The following data is part of a premarket notification filed by Medart A/s with the FDA for Medart Model 610 Co2 Laser System & Accessories.
| Device ID | K083123 |
| 510k Number | K083123 |
| Device Name: | MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDART A/S VALSEHOLMEN 11-13 Hvidovre, DK 2650 |
| Contact | Olav Balle-peterson |
| Correspondent | Olav Balle-peterson MEDART A/S VALSEHOLMEN 11-13 Hvidovre, DK 2650 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-22 |
| Decision Date | 2009-11-24 |
| Summary: | summary |