The following data is part of a premarket notification filed by A.r.c. Laser Gmbh with the FDA for Foxq 980 Laser.
| Device ID | K091059 |
| 510k Number | K091059 |
| Device Name: | FOXQ 980 LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | A.R.C. LASER GMBH 3202 TOWER OAKS BLVD SUITE 300 Rockville, MD 20852 |
| Contact | Kirsten Paulson |
| Correspondent | Kirsten Paulson A.R.C. LASER GMBH 3202 TOWER OAKS BLVD SUITE 300 Rockville, MD 20852 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-08-13 |
| Summary: | summary |