The following data is part of a premarket notification filed by A.r.c. Laser Gmbh with the FDA for Wolf445nm.
| Device ID | K192272 |
| 510k Number | K192272 |
| Device Name: | Wolf445nm |
| 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 | 2019-08-22 |
| Decision Date | 2020-03-17 |