The following data is part of a premarket notification filed by A.r.c. Laser Gmbh with the FDA for A.r.c. Laser Surgical Fibers And Probes.
| Device ID | K161403 |
| 510k Number | K161403 |
| Device Name: | A.R.C. Laser Surgical Fibers And Probes |
| Classification | Powered Laser Surgical Instrument |
| Applicant | A.R.C. LASER GMBH BESSEMER ST. 14 Nurnberg, DE 90411 |
| Contact | Angela Thyzel |
| Correspondent | Angela Thyzel A.R.C. LASER GMBH BESSEMER ST. 14 Nurnberg, DE 90411 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-20 |
| Decision Date | 2016-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260155591921 | K161403 | 000 |
| 4260155591808 | K161403 | 000 |
| 04260155591792 | K161403 | 000 |
| 04260155591785 | K161403 | 000 |
| 04260155591778 | K161403 | 000 |
| 04260155591761 | K161403 | 000 |
| 04260155590443 | K161403 | 000 |
| 04260155591747 | K161403 | 000 |
| 04260155592256 | K161403 | 000 |
| 04260155592126 | K161403 | 000 |
| 04260155591983 | K161403 | 000 |
| 04260155592287 | K161403 | 000 |
| 4260155591815 | K161403 | 000 |
| 4260155591822 | K161403 | 000 |
| 04260155591914 | K161403 | 000 |
| 04260155591907 | K161403 | 000 |
| 04260155591891 | K161403 | 000 |
| 04260155591884 | K161403 | 000 |
| 04260155591877 | K161403 | 000 |
| 04260155591655 | K161403 | 000 |
| 04260155591853 | K161403 | 000 |
| 04260155591846 | K161403 | 000 |
| 04260155591426 | K161403 | 000 |
| 04260155591730 | K161403 | 000 |
| 04260155591938 | K161403 | 000 |
| 04260155592348 | K161403 | 000 |