The following data is part of a premarket notification filed by A.r.c. Laser Gmbh with the FDA for Fox 1-980, Fox Q-1064, Fox-q-810.
| Device ID | K073322 |
| 510k Number | K073322 |
| Device Name: | FOX 1-980, FOX Q-1064, FOX-Q-810 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | A.R.C. LASER GMBH 3202 TOWER OAKS BLVD SUITE 300 Rockville, MD 20852 |
| Contact | Kirsten H Paulson |
| Correspondent | Kirsten H 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 | 2007-11-26 |
| Decision Date | 2008-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260155590078 | K073322 | 000 |
| 04260155593017 | K073322 | 000 |