The following data is part of a premarket notification filed by Quantel Derma Gmbh with the FDA for Exelo2, Model 4010.
| Device ID | K090639 |
| 510k Number | K090639 |
| Device Name: | EXELO2, MODEL 4010 |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | QUANTEL DERMA GMBH 601 HAGGERTY LN. Bozeman, MT 59715 |
| Contact | Michael Johnson |
| Correspondent | Michael Johnson QUANTEL DERMA GMBH 601 HAGGERTY LN. Bozeman, MT 59715 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-10 |
| Decision Date | 2009-10-29 |
| Summary: | summary |